Gastrointestinal InjuryPhase 4OPT-PEACENCT03198741
Mono- Versus Dual antiPlatelet Therapy During 6-12 Months After New Generation Drug Eluting Stent Implantation
A Phase 4 study testing Aspirin + clopidogrel, Clopidogrel monotherapy and Aspirin monotherapy in people with Gastrointestinal Injury and Ischemic Heart Disease, run by Shenyang Northern Hospital at 1 site in China.
Trial summary
Long-term DAPT is recommended after percutaneous coronary intervention (PCI) in patients with coronary artery disease. However, antiplatelet therapy may have adverse consequences, the most common of which is gastrointestinal mucosal injury with ulceration and bleeding. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastrointestinal Injury, Ischemic Heart Disease
- What is being tested?
- Aspirin + clopidogrel, Clopidogrel monotherapy and Aspirin monotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 783 participants
- Where
- 1 siteChina
- Study dates
- 13 Jul 2017to 13 Aug 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with age of 18-80 years;
- Presentation with silent ischemia, stable angina, or non-ST-segment elevation acute coronary syndrome with GRACE score <140 on admission;
- PCI only with implantation of current generation drug-eluting stent(s) for coronary artery disease during the present admission [current generation DES refers to DES with thin cobalt-chromium or platinum-chromium struts, with a durable or biodegradable polymer eluting a rapamycin-analogue antiproliferative agent. The current major DES available in China market include: EXCEL and EXCEL 2 (JW Medical System, Weihai, China), Tivoli（Essen Technology, Beijing, China), Endeavor Resolute (Medtronic Inc., Minnesota, USA), FireHawk (MicroPort Medical (Group) Co., Ltd, Shanghai, China), BuMA (SinoMedical,China),Xience V (Abbott Laboratories, Abbott Park, Illinois, USA), Xience Prime (Abbott Laboratories, Abbott Park, Illinois, USA), Promus Element and Synergy (BostonTechnologies, Massachusetts, USA)].
- PCI resulted in complete revascularization (successful PCI treatment of all epicardial coronary lesions with diameter stenosis >70% or intermediate lesions with FFR ≤0.80);
- Intended treatment with dual antiplatelet therapy (aspirin + clopidogrel) after the DES procedure for at least 6 months;
- Agreement to comply with all study procedures.
- Written informed consent provided.
Who cannot join
- Presentation with STEMI;
- Left main disease (diameter stenosis >30% );
- Any prior coronary stent implantation during the last year prior to the index procedure;
- Implantation of of first-generation drug-eluting stents or bioabsorbable scaffolds during the index procedure;
- Implantation of >4 stents during the index procedure;
- Any prior stent thrombosis;
Show all 27Show fewer
- Any active gastrointestinal bleeding or ulcers, or prior gastrointestinal bleeding or ulcers within the last 24 months;
- Prior gastrointestinal tract or abdominal surgery other than simple procedures which would not change the gastrointestinal tract anatomy, such as polyp removal, cholecystectomy or appendectomy;
- Contraindications to the AMCE test, including suspected or known gastrointestinal obstruction, stenosis, fistula, diverticula, etc.; presence of gastrointestinal obstruction symptoms such as pain or dysphagia; inoperative conditions or refusal to undergo abdominal surgery if required (i.e, if the capsule will not pass and cannot be removed by endoscopy)
- Severe hemorrhoids (phase 3-4 according to guidelines of American Society of Colon and Rectal Surgery);
- LVEF <0.40 on admission according to cardiac ultrasound;
- Renal dysfunction (eGFR <30ml/min/1.73m2);
- Active hepatitis or ALT >3 times upper limits of normal on admission;
- Uncontrolled severe hypertension (>180/110mmHg);
- Hemoglobin <100 g/L;
- Platelet count <100×109/L;
- Planned use of a proton pump inhibitor, gastric mucosa protectant or any other antacid agent after study enrollment；
- Required use of oral anticoagulation (warfarin or other factor II or factor X inhibitors);
- Inability to take 12-month DAPT for any reason;
- Mandatory use of >6 month DAPT (i.e. contraindication to aspirin or clopidogrel monotherapy after 6 months);
- Any comorbidity with estimated survival time <12 months (e.g. progressive cancer, chronic obstructive lung disease, etc.);
- Any contraindication to MRI examination, including implantation of an MRI-incompatible pacemaker, defibrillator, or other ferromagnetic material; etc.
- Pregnant or plan to be pregnant within 1 year;
- Any condition that may interfere with any study procedures, such as dementia, immobility, alcohol use, etc.;
- Planned surgery within 1 year;
- Taking iron supplement;
- Participating in any other clinical trial of an investigational drug or device that has not met its primary endpoint.
Trial locations and contacts
1 site in 1 country.
China1 site
General Hospital of Shenyang Military Region
Shenyang, Liaoning, 110016
About this study
Official title: COmparison of Mono- Versus Dual antiPlatelet Therapy During 6-12 Months After New Generation Drug Eluting Stent Implantation for Prevention of Gastrointestinal Injury Evaluated by Ankon Magnetically Controlled Capsule Endoscopy
Long-term DAPT is recommended after percutaneous coronary intervention (PCI) in patients with coronary artery disease. However, antiplatelet therapy may have adverse consequences, the most common of which is gastrointestinal mucosal injury with ulceration and bleeding. The extent to which an an abbreviated DAPT strategy reduces gastrointestinal mucosal injury has not been studied, principally due to the lack of sensitive, noninvasive measurements capable of detecting gastrointestinal injury.ANKON® magnetically controlled capsule endoscopy (AMCE) is a non-invasive, active controlled system which affords assessment of the stomach and entire small intestine.The current randomized study will assess gastrointestinal mucosal injury and bleeding via AMCE in patients on three different antiplatelet regimens and establish a gastrointestinal mucosal injury scoring system which may prove useful in guiding optimal antiplatelet agent usage after PCI.
Read the detailed description
Dual antiplatelet therapy (DAPT) with aspirin and a platelet P2Y12 receptor inhibitor has become the cornerstone for secondary prevention of coronary artery disease. Long-term DAPT is recommended after percutaneous coronary intervention (PCI) in patients with coronary artery disease to prevent future thrombotic events arising from the stent or untreated coronary lesions. However, antiplatelet therapy may have adverse consequences, the most common of which is gastrointestinal mucosal injury with ulceration and bleeding. The frequency of gastrointestinal complications increases with the duration of DAPT. Studies in patients treated with current generation drug-eluting stents have demonstrated that shortened DAPT regimens reduce the risk of bleeding events with small ischemic risk. However, the optimal duration of DAPT is still controversial. The extent to which an an abbreviated DAPT strategy reduces gastrointestinal mucosal injury has not been studied, principally due to the lack of sensitive, noninvasive measurements capable of detecting gastrointestinal injury.
Endoscopic examination of the gastric mucosa (gastroscopy) has high sensitivity and accuracy to detect gastrointestinal injury and bleeding. However, endoscopy is invasive and thus has no role in screening for sub-clinical gastrointestinal bleeding in patients undergoing PCI. Rather, endoscopy examinations are reserved for patients with active bleeding to identify the location of origin and etiology of the bleed. Moreover, gastroenterologists often refuse to perform gastroscopy in patients on DAPT given the risk of iatrogenic trauma with excessive hemorrhage. To minimize this risk, one or both antiplatelet agents often have to be discontinued for several days prior to the procedure, delaying the diagnosis while increasing the risk of stent thrombosis. Finally, upper endoscopy can only detect pathology related to the stomach and duodenum, as it does not visualize the remainder of the small intestine.
ANKON® magnetically controlled capsule endoscopy (AMCE) is a non-invasive, active controlled system which affords assessment of the stomach and entire small intestine. In the AMCE procedure, the patient swallows a capsule containing an endoscope which is actively maneuvered via magnetic control in the stomach, and then passes through the gastrointestinal track until its ultimate excretion. AMCE has several advantages compared to standard endoscopy. AMCE is noninvasive, painless and convenient, and can be re-administered as necessary. Patient acceptance of AMCE is likely to be substantially higher than standard endoscopy as the procedure involves only swallowing a capsule endoscope, without anesthesia or recovery time. Compared to standard endoscopy, AMCE provides more comprehensive detection of gastrointestinal pathology as it visualizes not only the stomach and duodenum, but the entire small intestine. Finally, discontinuation of antiplatelet drugs during AMCE is not necessary. Because of these advantages, AMCE can be used for screening of gastrointestinal mucosal lesions prior to clinical bleeding, including early detection of small areas of focal and concealed bleeding. Detection of preclinical gastric ulcerations or bleeding may be useful in directing preventative measures, whether gastro-protective therapies or DAPT discontinuation. A large-scale, randomized trial has confirmed that the sensitivity and specificity of AMCE for the detection of focal lesions of the gastrointestinal tract is similar to standard endoscopy. However, the potential utility of AMCE in patients receiving antiplatelet therapy after PCI has not been reported.
The current randomized study will evaluate AMCE as a tool to assess gastrointestinal mucosal injury and bleeding in patients on DAPT; evaluate the relative rates of gastrointestinal injury in patients on three different antiplatelet regimens; and establish a gastrointestinal mucosal injury scoring system which may prove useful in guiding optimal antiplatelet agent usage after PCI.
- Conditions
- Gastrointestinal Injury, Ischemic Heart Disease
- Being tested
- Aspirin + clopidogrel, Clopidogrel monotherapy, Aspirin monotherapy
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin + clopidogrelDrug
After randomization(6 months±2 weeks after enrollment),receive aspirin 100mg/d + clopidogrel 75mg/d for an additional 6 months. The above treatments between 6 and 12 months are double-blinded.
Clopidogrel monotherapyDrug
Also called Clopidogrel + placebo
After randomization(6 months±2 weeks after enrollment),receive clopidogrel 75mg/d + placebo (clopidogrel monotherapy group) for an additional 6 months. The above treatments between 6 and 12 months are double-blinded.
Aspirin monotherapyDrug
Also called Aspirin + clopidogrel
After randomization(6 months±2 weeks after enrollment),receive aspirin 100mg/d + placebo (aspirin monotherapy group) for an additional 6 months. The above treatments between 6 and 12 months are double-blinded.
| Study group | Role | What they receive |
|---|---|---|
| Aspirin+clopidogrel | Active comparator | Open label clopidogrel (75mg/d) plus aspirin (100mg/d) for first 6 months after enrollment. At 6 months (±2 weeks),continue aspirin + clopidogrel (12-month DAPT group).The treatments between 6 and 12 months are double-blinded.
Evaluation of gastric and intestinal mucosal lesions by AMCE will be performed at the time of screening, randomization (at 6 months ±2 weeks) and 6 months thereafter (at 12 months ±2 weeks). Receives: Drug: Aspirin + clopidogrel |
| Aspirin | Experimental | Open label clopidogrel (75mg/d) plus aspirin (100mg/d) for first 6 months after enrollment. At 6 months (±2 weeks),receive aspirin + placebo (aspirin monotherapy group) for an additional 6 months. The above treatments between 6 and 12 months are double-blinded.
Evaluation of gastric and intestinal mucosal lesions by AMCE will be performed at the time of screening, randomization (at 6 months ±2 weeks) and 6 months thereafter (at 12 months ±2 weeks). Receives: Drug: Aspirin monotherapy |
| Clopidogrel | Experimental | Open label clopidogrel (75mg/d) plus aspirin (100mg/d) for first 6 months after enrollment. At 6 months (±2 weeks),receive clopidogrel + placebo (clopidogrel monotherapy group) for an additional 6 months. The above treatments between 6 and 12 months are double-blinded.
Evaluation of gastric and intestinal mucosal lesions by AMCE will be performed at the time of screening, randomization (at 6 months ±2 weeks) and 6 months thereafter (at 12 months ±2 weeks). Receives: Drug: Clopidogrel monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal mucosal Injury (erosion, ulceration or bleeding)
Detected by AMCE
Measured: 12 months after enrollment (i.e. 6 months after randomization)
Secondary outcomes (10)
The severity of gastric and intestinal mucosal lesions
Detected by AMCE and calculated with a score system
Measured: During the first 6 months after study enrollment (prior to randomization)
The severity of gastric and intestinal mucosal lesions
Detected by AMCE and calculated with a score system
Measured: After randomization (i.e. between 6 months and 12 months after study enrollment)
Clinical indicated bleeding of the upper gastrointestinal tract
- Hematemesis is defined as vomiting of blood or blood clots, and generally indicates bleeding of the upper gastrointestinal tract.
- Hematochezia is the passage of fresh blood per anus, usually in or with stools, and typically signifies lower GI tract bleeding.
- Melena is the passage of black, tarry stool and typically signifies upper tract GI bleeding.
- The positive fecal occult blood refers to blood in the feces that is not visibly apparent (unlike other types of blood in stool such as melena or hematochezia).
Measured: During 6 months after study enrollment (prior to randomization)
Clinical indicated evident gastrointestinal hemorrhage
- Hematemesis is defined as vomiting of blood or blood clots, and generally indicates bleeding of the upper gastrointestinal tract.
- Hematochezia is the passage of fresh blood per anus, usually in or with stools, and typically signifies lower GI tract bleeding.
- Melena is the passage of black, tarry stool and typically signifies upper tract GI bleeding.
- The positive fecal occult blood refers to blood in the feces that is not visibly apparent (unlike other types of blood in stool such as melena or hematochezia).
Measured: After randomization (i.e. between 6 months and 12 months after study enrollment)
Clinical indicated gastrointestinal hemorrhage
- Hematemesis is defined as vomiting of blood or blood clots, and generally indicates bleeding of the upper gastrointestinal tract.
- Hematochezia is the passage of fresh blood per anus, usually in or with stools, and typically signifies lower GI tract bleeding.
- Melena is the passage of black, tarry stool and typically signifies upper tract GI bleeding.
- The positive fecal occult blood refers to blood in the feces that is not visibly apparent (unlike other types of blood in stool such as melena or hematochezia).
Measured: 12 months after enrollment (i.e. 6 months after randomization)
Gastrointestinal symptoms
pain, nausea/vomiting, dysphagia, other discomfort
Measured: 12 months after enrollment (i.e. 6 months after randomization)
All bleeding
BARC types 1-5
Measured: 12 months after enrollment (i.e. 6 months after randomization)
Target lesion failure
TLF: cardiac death, target-vessel MI, or clinically-driven target lesion revascularization
Measured: 12 months after enrollment (i.e. 6 months after randomization)
Net adverse clinical events
NACE, defined as TLF or BARC type 2-5 bleeding
Measured: 12 months after enrollment (i.e. 6 months after randomization)
Stent thrombosis
ARC definite, probable, or definite/probable
Measured: 12 months after enrollment (i.e. 6 months after randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start13 Jul 2017
- Primary completion13 Aug 2020
- Study completion13 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 783 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenyang Northern Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Changhai Hospital, ANKON medical technologies (Shanghai)Co.,LTD
- Responsible party
- Principal investigator, Han Yaling, Shenyang Northern Hospital
- Investigators
- Yaling Han, PhD, Principal investigator, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198741
- Sponsor's protocol ID
- SYNH-20170602
- Acronym
- OPT-PEACE
- Status last verified
- May 2022
- First submitted
- 19 Jun 2017
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li Y, Wang X, Bao D, Liao Z, Li J, Han X, Wang H, Xu K, Li Z, Stone GW, Han Y. Optimal antiplatelet therapy for prevention of gastrointestinal injury evaluated by ANKON magnetically controlled capsule endoscopy: Rationale and design of the OPT-PEACE trial. Am Heart J. 2020 Oct;228:8-16. doi: 10.1016/j.ahj.2020.06.004. Epub 2020 Jun 15.
PubMed 32745734Han Y, Liao Z, Li Y, Zhao X, Ma S, Bao D, Qiu M, Deng J, Wang J, Qu P, Jiang C, Jia S, Yang S, Ru L, Feng J, Gao W, Huang Y, Tao L, Han Y, Yang K, Wang X, Zhang W, Wang B, Li Y, Yang Y, Li J, Sheng J, Ma Y, Cui M, Ma S, Wang X, Li Z, Stone GW. Magnetically Controlled Capsule Endoscopy for Assessment of Antiplatelet Therapy-Induced Gastrointestinal Injury. J Am Coll Cardiol. 2022 Jan 18;79(2):116-128. doi: 10.1016/j.jacc.2021.10.028. Epub 2021 Nov 6.
PubMed 34752902He C, Li Y, Jiang X, Jiang MN, Zhao XX, Ma SR, Bao D, Qiu MH, Deng J, Wang JH, Qu P, Jiang CM, Jia SB, Yang SQ, Ru LS, Feng J, Gao W, Huang YH, Tao L, Han Y, Yang K, Wang XY, Zhang WJ, Wang BM, Li Y, Yang YL, Li JX, Sheng JQ, Ma YT, Cui M, Ma SC, Wang XZ, Li ZS, Liao Z, Han YL, Stone GW. Progression of Gastrointestinal Injury During Antiplatelet Therapy After Percutaneous Coronary Intervention: A Secondary Analysis of the OPT-PEACE Randomized Clinical Trial. JAMA Netw Open. 2023 Nov 1;6(11):e2343219. doi: 10.1001/jamanetworkopen.2023.43219.
PubMed 37976067
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COmparison of Mono- Versus Dual antiPlatelet Therapy During 6-12 Months After New Generation Drug Eluting Stent Implantation for Prevention of Gastrointestinal Injury Evaluated by Ankon Magnetically Controlled Capsule Endoscopy
- ClinicalTrials.gov ID
- NCT03198741
- Acronym / sponsor ID
- OPT-PEACE / SYNH-20170602
- Conditions
- Gastrointestinal Injury, Ischemic Heart Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 783 participants (actual)
- Lead sponsor
- Shenyang Northern HospitalUniversity, hospital or other
- Collaborators
- Changhai Hospital, ANKON medical technologies (Shanghai)Co.,LTD
- Study start
- 13 Jul 2017 (actual)
- Primary completion
- 13 Aug 2020 (actual)
- Study completion
- 13 Aug 2020 (actual)
- First posted
- 26 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Long-term DAPT is recommended after percutaneous coronary intervention (PCI) in patients with coronary artery disease. However, antiplatelet therapy may have adverse consequences, the most common of which is gastrointestinal mucosal injury with ulceration and bleeding. The extent to which an an abbreviated DAPT strategy reduces gastrointestinal mucosal injury has not been studied, principally due to the lack of sensitive, noninvasive measurements capable of detecting gastrointestinal injury.ANKON® magnetically controlled capsule endoscopy (AMCE) is a non-invasive, active controlled system which affords assessment of the stomach and entire small intestine.The current randomized study will assess gastrointestinal mucosal injury and bleeding via AMCE in patients on three different antiplatelet regimens and establish a gastrointestinal mucosal injury scoring system which may prove useful in guiding optimal antiplatelet agent usage after PCI.
Detailed description
Dual antiplatelet therapy (DAPT) with aspirin and a platelet P2Y12 receptor inhibitor has become the cornerstone for secondary prevention of coronary artery disease. Long-term DAPT is recommended after percutaneous coronary intervention (PCI) in patients with coronary artery disease to prevent future thrombotic events arising from the stent or untreated coronary lesions. However, antiplatelet therapy may have adverse consequences, the most common of which is gastrointestinal mucosal injury with ulceration and bleeding. The frequency of gastrointestinal complications increases with the duration of DAPT. Studies in patients treated with current generation drug-eluting stents have demonstrated that shortened DAPT regimens reduce the risk of bleeding events with small ischemic risk. However, the optimal duration of DAPT is still controversial. The extent to which an an abbreviated DAPT strategy reduces gastrointestinal mucosal injury has not been studied, principally due to the lack of sensitive, noninvasive measurements capable of detecting gastrointestinal injury.
Endoscopic examination of the gastric mucosa (gastroscopy) has high sensitivity and accuracy to detect gastrointestinal injury and bleeding. However, endoscopy is invasive and thus has no role in screening for sub-clinical gastrointestinal bleeding in patients undergoing PCI. Rather, endoscopy examinations are reserved for patients with active bleeding to identify the location of origin and etiology of the bleed. Moreover, gastroenterologists often refuse to perform gastroscopy in patients on DAPT given the risk of iatrogenic trauma with excessive hemorrhage. To minimize this risk, one or both antiplatelet agents often have to be discontinued for several days prior to the procedure, delaying the diagnosis while increasing the risk of stent thrombosis. Finally, upper endoscopy can only detect pathology related to the stomach and duodenum, as it does not visualize the remainder of the small intestine.
ANKON® magnetically controlled capsule endoscopy (AMCE) is a non-invasive, active controlled system which affords assessment of the stomach and entire small intestine. In the AMCE procedure, the patient swallows a capsule containing an endoscope which is actively maneuvered via magnetic control in the stomach, and then passes through the gastrointestinal track until its ultimate excretion. AMCE has several advantages compared to standard endoscopy. AMCE is noninvasive, painless and convenient, and can be re-administered as necessary. Patient acceptance of AMCE is likely to be substantially higher than standard endoscopy as the procedure involves only swallowing a capsule endoscope, without anesthesia or recovery time. Compared to standard endoscopy, AMCE provides more comprehensive detection of gastrointestinal pathology as it visualizes not only the stomach and duodenum, but the entire small intestine. Finally, discontinuation of antiplatelet drugs during AMCE is not necessary. Because of these advantages, AMCE can be used for screening of gastrointestinal mucosal lesions prior to clinical bleeding, including early detection of small areas of focal and concealed bleeding. Detection of preclinical gastric ulcerations or bleeding may be useful in directing preventative measures, whether gastro-protective therapies or DAPT discontinuation. A large-scale, randomized trial has confirmed that the sensitivity and specificity of AMCE for the detection of focal lesions of the gastrointestinal tract is similar to standard endoscopy. However, the potential utility of AMCE in patients receiving antiplatelet therapy after PCI has not been reported.
The current randomized study will evaluate AMCE as a tool to assess gastrointestinal mucosal injury and bleeding in patients on DAPT; evaluate the relative rates of gastrointestinal injury in patients on three different antiplatelet regimens; and establish a gastrointestinal mucosal injury scoring system which may prove useful in guiding optimal antiplatelet agent usage after PCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aspirin+clopidogrel | Active comparator | Drug: Aspirin + clopidogrelOpen label clopidogrel (75mg/d) plus aspirin (100mg/d) for first 6 months after enrollment. At 6 months (±2 weeks),continue aspirin + clopidogrel (12-month DAPT group).The treatments between 6 and 12 months are double-blinded. Evaluation of gastric and intestinal mucosal lesions by AMCE will be performed at the time of screening, randomization (at 6 months ±2 weeks) and 6 months thereafter (at 12 months ±2 weeks). |
| Aspirin | Experimental | Drug: Aspirin monotherapyOpen label clopidogrel (75mg/d) plus aspirin (100mg/d) for first 6 months after enrollment. At 6 months (±2 weeks),receive aspirin + placebo (aspirin monotherapy group) for an additional 6 months. The above treatments between 6 and 12 months are double-blinded. Evaluation of gastric and intestinal mucosal lesions by AMCE will be performed at the time of screening, randomization (at 6 months ±2 weeks) and 6 months thereafter (at 12 months ±2 weeks). |
| Clopidogrel | Experimental | Drug: Clopidogrel monotherapyOpen label clopidogrel (75mg/d) plus aspirin (100mg/d) for first 6 months after enrollment. At 6 months (±2 weeks),receive clopidogrel + placebo (clopidogrel monotherapy group) for an additional 6 months. The above treatments between 6 and 12 months are double-blinded. Evaluation of gastric and intestinal mucosal lesions by AMCE will be performed at the time of screening, randomization (at 6 months ±2 weeks) and 6 months thereafter (at 12 months ±2 weeks). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patients with age of 18-80 years;
- Presentation with silent ischemia, stable angina, or non-ST-segment elevation acute coronary syndrome with GRACE score <140 on admission;
- PCI only with implantation of current generation drug-eluting stent(s) for coronary artery disease during the present admission [current generation DES refers to DES with thin cobalt-chromium or platinum-chromium struts, with a durable or biodegradable polymer eluting a rapamycin-analogue antiproliferative agent. The current major DES available in China market include: EXCEL and EXCEL 2 (JW Medical System, Weihai, China), Tivoli（Essen Technology, Beijing, China), Endeavor Resolute (Medtronic Inc., Minnesota, USA), FireHawk (MicroPort Medical (Group) Co., Ltd, Shanghai, China), BuMA (SinoMedical,China),Xience V (Abbott Laboratories, Abbott Park, Illinois, USA), Xience Prime (Abbott Laboratories, Abbott Park, Illinois, USA), Promus Element and Synergy (BostonTechnologies, Massachusetts, USA)].
- PCI resulted in complete revascularization (successful PCI treatment of all epicardial coronary lesions with diameter stenosis >70% or intermediate lesions with FFR ≤0.80);
- Intended treatment with dual antiplatelet therapy (aspirin + clopidogrel) after the DES procedure for at least 6 months;
Key exclusion criteria (27 listed)
- Presentation with STEMI;
- Left main disease (diameter stenosis >30% );
- Any prior coronary stent implantation during the last year prior to the index procedure;
- Implantation of of first-generation drug-eluting stents or bioabsorbable scaffolds during the index procedure;
- Implantation of >4 stents during the index procedure;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin + clopidogrelAfter randomization(6 months±2 weeks after enrollment),receive aspirin 100mg/d + clopidogrel 75mg/d for an additional 6 months. The above treatments between 6 and 12 months are double-blinded. | Drug | Aspirin+clopidogrel |
| Clopidogrel monotherapyAlso: Clopidogrel + placeboAfter randomization(6 months±2 weeks after enrollment),receive clopidogrel 75mg/d + placebo (clopidogrel monotherapy group) for an additional 6 months. The above treatments between 6 and 12 months are double-blinded. | Drug | Clopidogrel |
| Aspirin monotherapyAlso: Aspirin + clopidogrelAfter randomization(6 months±2 weeks after enrollment),receive aspirin 100mg/d + placebo (aspirin monotherapy group) for an additional 6 months. The above treatments between 6 and 12 months are double-blinded. | Drug | Aspirin |
Primary outcome
Gastrointestinal mucosal Injury (erosion, ulceration or bleeding)
Time frame: 12 months after enrollment (i.e. 6 months after randomization)
Detected by AMCE
10 secondary outcomes
The severity of gastric and intestinal mucosal lesions
Time frame: During the first 6 months after study enrollment (prior to randomization)
The severity of gastric and intestinal mucosal lesions
Time frame: After randomization (i.e. between 6 months and 12 months after study enrollment)
Clinical indicated bleeding of the upper gastrointestinal tract
Time frame: During 6 months after study enrollment (prior to randomization)
Clinical indicated evident gastrointestinal hemorrhage
Time frame: After randomization (i.e. between 6 months and 12 months after study enrollment)
Clinical indicated gastrointestinal hemorrhage
Time frame: 12 months after enrollment (i.e. 6 months after randomization)
Gastrointestinal symptoms
Time frame: 12 months after enrollment (i.e. 6 months after randomization)
All bleeding
Time frame: 12 months after enrollment (i.e. 6 months after randomization)
Target lesion failure
Time frame: 12 months after enrollment (i.e. 6 months after randomization)
Net adverse clinical events
Time frame: 12 months after enrollment (i.e. 6 months after randomization)
Stent thrombosis
Time frame: 12 months after enrollment (i.e. 6 months after randomization)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Background: PubMed 32745734Li Y, Wang X, Bao D, Liao Z, Li J, Han X, Wang H, Xu K, Li Z, Stone GW, Han Y. Optimal antiplatelet therapy for prevention of gastrointestinal injury evaluated by ANKON magnetically controlled capsule endoscopy: Rationale and design of the OPT-PEACE trial. Am Heart J. 2020 Oct;228:8-16. doi: 10.1016/j.ahj.2020.06.004. Epub 2020 Jun 15.
- Background: PubMed 34752902Han Y, Liao Z, Li Y, Zhao X, Ma S, Bao D, Qiu M, Deng J, Wang J, Qu P, Jiang C, Jia S, Yang S, Ru L, Feng J, Gao W, Huang Y, Tao L, Han Y, Yang K, Wang X, Zhang W, Wang B, Li Y, Yang Y, Li J, Sheng J, Ma Y, Cui M, Ma S, Wang X, Li Z, Stone GW. Magnetically Controlled Capsule Endoscopy for Assessment of Antiplatelet Therapy-Induced Gastrointestinal Injury. J Am Coll Cardiol. 2022 Jan 18;79(2):116-128. doi: 10.1016/j.jacc.2021.10.028. Epub 2021 Nov 6.
- Derived from this study: PubMed 37976067He C, Li Y, Jiang X, Jiang MN, Zhao XX, Ma SR, Bao D, Qiu MH, Deng J, Wang JH, Qu P, Jiang CM, Jia SB, Yang SQ, Ru LS, Feng J, Gao W, Huang YH, Tao L, Han Y, Yang K, Wang XY, Zhang WJ, Wang BM, Li Y, Yang YL, Li JX, Sheng JQ, Ma YT, Cui M, Ma SC, Wang XZ, Li ZS, Liao Z, Han YL, Stone GW. Progression of Gastrointestinal Injury During Antiplatelet Therapy After Percutaneous Coronary Intervention: A Secondary Analysis of the OPT-PEACE Randomized Clinical Trial. JAMA Netw Open. 2023 Nov 1;6(11):e2343219. doi: 10.1001/jamanetworkopen.2023.43219.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaling Han, PhD principal investigator
General Hospital of Shenyang Military Region
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin + clopidogrel, Clopidogrel monotherapy and Aspirin monotherapy in people with Gastrointestinal Injury and Ischemic Heart Disease, run by Shenyang Northern Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal mucosal Injury (erosion, ulceration or bleeding) (time frame: 12 months after enrollment (i.e. 6 months after randomization)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03198741, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.