Coronary Heart DiseasePhase 4NCT02435797
Effect of Nicorandil for the Patients of Acute ST Segment Elevation Myocardial Infarction
A Phase 4 study testing Nicorandil and normal saline in people with Coronary Heart Disease, run by Xuzhou Central Hospital at 1 site in China.
Trial summary
To evaluate whether nicorandil as an adjunctive therapy for acute myocardial infarction (AMI) reduces reperfusion injury. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Nicorandil and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to Oct 2016
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute ST Segment Elevation Myocardial Infarction (ASTEMI) defined as typical chest pain lasting >30min within the previous 12 h, with a clear ST-segment elevation of >0.1millivolt(mV) in ≥2 contiguous electrocardiographic leads, and the value of troponin I(TNI) above the maximum peak in the normal range.
- Age20-80,All genders
- The first myocardial infarction, and there is no history of PCI therapy and coronary artery bypass grafting
- The infarct-related artery(IRA) is totally occlusive
- Blood pressure is higher than 90/60 millimeters of mercury（mmHg）
- The time from myocardial infarction onset to reach the hospital is less than 12 hs
- Successful interventional treatment, the residual stenosis of IRA is less than 30% ,
- TIMI flow grade 3
Who cannot join
- kidney dysfunction (creatinine >2 mg/dl),
- History of previous liver disease,
- Cardiogenic shock,
- History of myocardial infarction (MI)
- History of coronary artery bypass grafting
- History of allergic response to drugs
- Right ventricular infarction
- Severe hypovolemia
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221000
Feng chunguang, PhD, +8618936376559, fcg999@163.com
Feng chunguang, PhD
About this study
Official title: Effect of Early Administration of Intracoronary Nicorandil Via Thrombus Aspiration Catheter Device During Primary Percutaneous Coronary Intervention for the Patients of Acute ST Segment Elevation Myocardial Infarction
To evaluate whether nicorandil as an adjunctive therapy for acute myocardial infarction (AMI) reduces reperfusion injury.
Read the detailed description
Reperfusion injury might occur in patients with acute ST segment elevation myocardial infarction undergoing the primary percutaneous coronary intervention(P-PCI),characterized by myocardial stunning, reperfusion-induced arrhythmia, microvascular dysfunction and myocardial cellular apoptosis, etc.
Nicorandil is an antianginal agent with a dual mechanism of action: nitrate and K+ATP channel opener. The nitrate action causes vasodilation of systemic veins and epicardial coronary arteries, while the adenosine triphosphate (ATP)-sensitive potassium channel opener action causes vasodilation of peripheral and coronary resistance arterioles. Nicorandil not only decreases preload and afterload but also increases coronary blood flow.
The study will compare the effectiveness between nicorandil and placebo of preventing the reperfusion injury and left ventricle remodeling in patients with acute ST segment elevation myocardial infarction undergoing the P-PCI.It is intended that before reperfusion injury ,nicorandil which was early used by intracoronary injection could prevent and release the microcirculatory spasm, release the coronary microvascular endothelial swelling,decrease embolism of atherosclerotic debris and thrombus formation.So,it could decrease the phenomenon of no-reflow/slow reflow,reperfusion-induced arrhythmia and worsening of chest pain.
- Conditions
- Coronary Heart Disease
- Being tested
- Nicorandil, normal saline
- Keywords
- nicorandil, primary percutaneous coronary intervention, acute ST segment elevation myocardial infarction, thrombus aspiration
- Medical subject headings
- Coronary Disease, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicorandilDrug
All patients received antiplatelet agents (aspirin, ticagrelor) and heparin.Diagnostic coronary angiography (CAG) was performed via the right (or left) femoral artery or radial artery using the Seldinger method.The guidewire was passed into the culprit lesion. Subjects in the NicorandilGroup were then given 2 mg intracoronary nicorandil through the lesions via thrombus aspiration catheter, and an additional intracoronary dose of 2 mg nicorandil before stent implantation. A minimum 5-min interval occurred between the first and second doses of nicorandil to reduce adverse effects.
normal salineDrug
All patients received antiplatelet agents (aspirin, ticagrelor) and heparin.Diagnostic coronary angiography (CAG) was performed via the right (or left) femoral artery or radial artery using the Seldinger method.The guidewire was passed into the culprit lesion. Normal saline in the Placebo Group were then given 2 ml through the lesions via thrombus aspiration catheter,and an additional intracoronary dose of 2 ml before stent implantation. A minimum 5-min interval occurred between the first and second injection.
| Study group | Role | What they receive |
|---|---|---|
| Nicorandil | Active comparator | Nicorandil for injection Receives: Drug: Nicorandil |
| normal saline | Placebo comparator | normal saline Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary composite endpoint (whether premature beats,atrial or ventricular tachycardia, atrial or ventricular fibrillation, and atrioventricular block appears;whether severity of chest pain is aggravated,and number of episodes chest pain)
The primary composite endpoint consisted of reperfusion-induced arrhythmia, worsening of chest pain, and no-reflow/slow reflow.
In perioperative period,we will observe whether the reperfusion-induced arrhythmia including atrial or ventricular premature beats,atrial or ventricular tachycardia, atrial or ventricular fibrillation, and atrioventricular block appears;whether the severity of chest pain is aggravated,and the number of episodes of chest pain will be recorded for patients who complains of chest pain that lasted for at least 30 min within the 24 h following onset of MI;Whether the phenomenon of no-reflow/slow reflow appears.No-reflow and slow flow are diagnosed when the thrombolysis in myocardial infarction(TIMI) flow grade is 2 or lower,despite successful PCI such as balloon angioplasty or stent insertion.
Measured: 24hours
Secondary outcomes (1)
the combined outcome of TIMI frame count (cTFC) of CAG and ST resolution (STR) of ECG
The cTFC was measured according to the method of Gibson et al, to determine blood flow at the time of coronary angiography. The cine frame counts derived from the injection of contrast medium to the peripheral landmark were measured .
In order to evaluate STR, the total sum of the ST segments elevation from the J point to the point reached 20ms later was calculated from the 12-lead ECG recorded before the start of reperfusion, and 90 min after the completion of reperfusion. The rate of improvement in ST elevation was classified as "complete resolution" (70% or more improvement) and "no resolution" (<70%).
Measured: 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startApr 2015
- Primary completionAug 2015 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuzhou Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Chunguang, Xuzhou Central Hospital
- Investigators
- Institute of Cardiovascular Disease Xuzhou Central Hospital, Study director, Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435797
- Sponsor's protocol ID
- W201416
- Status last verified
- May 2015
- First submitted
- 23 Apr 2015
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Moens AL, Claeys MJ, Timmermans JP, Vrints CJ. Myocardial ischemia/reperfusion-injury, a clinical view on a complex pathophysiological process. Int J Cardiol. 2005 Apr 20;100(2):179-90. doi: 10.1016/j.ijcard.2004.04.013.
PubMed 15823623Reffelmann T, Kloner RA. The "no-reflow" phenomenon: basic science and clinical correlates. Heart. 2002 Feb;87(2):162-8. doi: 10.1136/heart.87.2.162. No abstract available.
PubMed 11796561Costantini CO, Stone GW, Mehran R, Aymong E, Grines CL, Cox DA, Stuckey T, Turco M, Gersh BJ, Tcheng JE, Garcia E, Griffin JJ, Guagliumi G, Leon MB, Lansky AJ. Frequency, correlates, and clinical implications of myocardial perfusion after primary angioplasty and stenting, with and without glycoprotein IIb/IIIa inhibition, in acute myocardial infarction. J Am Coll Cardiol. 2004 Jul 21;44(2):305-12. doi: 10.1016/j.jacc.2004.03.058.
PubMed 15261923Tanaka A, Kawarabayashi T, Nishibori Y, Sano T, Nishida Y, Fukuda D, Shimada K, Yoshikawa J. No-reflow phenomenon and lesion morphology in patients with acute myocardial infarction. Circulation. 2002 May 7;105(18):2148-52. doi: 10.1161/01.cir.0000015697.59592.07.
PubMed 11994247Limbruno U, De Carlo M, Pistolesi S, Micheli A, Petronio AS, Camacci T, Fontanini G, Balbarini A, Mariani M, De Caterina R. Distal embolization during primary angioplasty: histopathologic features and predictability. Am Heart J. 2005 Jul;150(1):102-8. doi: 10.1016/j.ahj.2005.01.016.
PubMed 16084155De Luca G, Navarese EP, Suryapranata H. A meta-analytic overview of thrombectomy during primary angioplasty. Int J Cardiol. 2013 Jul 1;166(3):606-12. doi: 10.1016/j.ijcard.2011.11.102. Epub 2012 Jan 28.
PubMed 22284272Werner GS, Lang K, Kuehnert H, Figulla HR. Intracoronary verapamil for reversal of no-reflow during coronary angioplasty for acute myocardial infarction. Catheter Cardiovasc Interv. 2002 Dec;57(4):444-51. doi: 10.1002/ccd.10375.
PubMed 12455077Marzilli M, Orsini E, Marraccini P, Testa R. Beneficial effects of intracoronary adenosine as an adjunct to primary angioplasty in acute myocardial infarction. Circulation. 2000 May 9;101(18):2154-9. doi: 10.1161/01.cir.101.18.2154.
PubMed 10801755Taira N. Nicorandil as a hybrid between nitrates and potassium channel activators. Am J Cardiol. 1989 Jun 20;63(21):18J-24J. doi: 10.1016/0002-9149(89)90200-2.
PubMed 2525320Ota S, Nishikawa H, Takeuchi M, Nakajima K, Nakamura T, Okamoto S, Setsuda M, Makino K, Yamakado T, Nakano T. Impact of nicorandil to prevent reperfusion injury in patients with acute myocardial infarction: Sigmart Multicenter Angioplasty Revascularization Trial (SMART). Circ J. 2006 Sep;70(9):1099-104. doi: 10.1253/circj.70.1099.
PubMed 16936418Tsubokawa A, Ueda K, Sakamoto H, Iwase T, Tamaki S. Effect of intracoronary nicorandil administration on preventing no-reflow/slow flow phenomenon during rotational atherectomy. Circ J. 2002 Dec;66(12):1119-23. doi: 10.1253/circj.66.1119.
PubMed 12499617Lim SY, Bae EH, Jeong MH, Kang DG, Lee YS, Kim KH, Lee SH, Yoon KH, Hong SN, Park HW, Hong YJ, Kim JH, Kim W, Ahn YK, Cho JG, Park JC, Kang JC. Effect of combined intracoronary adenosine and nicorandil on no-reflow phenomenon during percutaneous coronary intervention. Circ J. 2004 Oct;68(10):928-32. doi: 10.1253/circj.68.928.
PubMed 15459466Kitakaze M, Asakura M, Kim J, Shintani Y, Asanuma H, Hamasaki T, Seguchi O, Myoishi M, Minamino T, Ohara T, Nagai Y, Nanto S, Watanabe K, Fukuzawa S, Hirayama A, Nakamura N, Kimura K, Fujii K, Ishihara M, Saito Y, Tomoike H, Kitamura S; J-WIND investigators. Human atrial natriuretic peptide and nicorandil as adjuncts to reperfusion treatment for acute myocardial infarction (J-WIND): two randomised trials. Lancet. 2007 Oct 27;370(9597):1483-93. doi: 10.1016/S0140-6736(07)61634-1.
PubMed 17964349Feng C, Liu Y, Wang L, Niu D, Han B. Effects of Early Intracoronary Administration of Nicorandil During Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction. Heart Lung Circ. 2019 Jun;28(6):858-865. doi: 10.1016/j.hlc.2018.05.097. Epub 2018 May 22.
PubMed 29891250
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Administration of Intracoronary Nicorandil Via Thrombus Aspiration Catheter Device During Primary Percutaneous Coronary Intervention for the Patients of Acute ST Segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02435797
- Acronym / sponsor ID
- W201416
- Conditions
- Coronary Heart Disease
- Keywords
- nicorandil, primary percutaneous coronary intervention, acute ST segment elevation myocardial infarction, thrombus aspiration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xuzhou Central HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 6 May 2015 (estimated)
- 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.
To evaluate whether nicorandil as an adjunctive therapy for acute myocardial infarction (AMI) reduces reperfusion injury.
Detailed description
Reperfusion injury might occur in patients with acute ST segment elevation myocardial infarction undergoing the primary percutaneous coronary intervention(P-PCI),characterized by myocardial stunning, reperfusion-induced arrhythmia, microvascular dysfunction and myocardial cellular apoptosis, etc.
Nicorandil is an antianginal agent with a dual mechanism of action: nitrate and K+ATP channel opener. The nitrate action causes vasodilation of systemic veins and epicardial coronary arteries, while the adenosine triphosphate (ATP)-sensitive potassium channel opener action causes vasodilation of peripheral and coronary resistance arterioles. Nicorandil not only decreases preload and afterload but also increases coronary blood flow.
The study will compare the effectiveness between nicorandil and placebo of preventing the reperfusion injury and left ventricle remodeling in patients with acute ST segment elevation myocardial infarction undergoing the P-PCI.It is intended that before reperfusion injury ,nicorandil which was early used by intracoronary injection could prevent and release the microcirculatory spasm, release the coronary microvascular endothelial swelling,decrease embolism of atherosclerotic debris and thrombus formation.So,it could decrease the phenomenon of no-reflow/slow reflow,reperfusion-induced arrhythmia and worsening of chest pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicorandil | Active comparator | Drug: NicorandilNicorandil for injection |
| normal saline | Placebo comparator | Drug: normal salinenormal saline |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Acute ST Segment Elevation Myocardial Infarction (ASTEMI) defined as typical chest pain lasting >30min within the previous 12 h, with a clear ST-segment elevation of >0.1millivolt(mV) in ≥2 contiguous electrocardiographic leads, and the value of troponin I(TNI) above the maximum peak in the normal range.
- Age20-80,All genders
- The first myocardial infarction, and there is no history of PCI therapy and coronary artery bypass grafting
- The infarct-related artery(IRA) is totally occlusive
- Blood pressure is higher than 90/60 millimeters of mercury（mmHg）
Key exclusion criteria (8 listed)
- kidney dysfunction (creatinine >2 mg/dl),
- History of previous liver disease,
- Cardiogenic shock,
- History of myocardial infarction (MI)
- History of coronary artery bypass grafting
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 |
|---|---|---|
| NicorandilAll patients received antiplatelet agents (aspirin, ticagrelor) and heparin.Diagnostic coronary angiography (CAG) was performed via the right (or left) femoral artery or radial artery using the Seldinger method.The guidewire was passed into the culprit lesion. Subjects in the NicorandilGroup were then given 2 mg intracoronary nicorandil through the lesions via thrombus aspiration catheter, and an additional intracoronary dose of 2 mg nicorandil before stent implantation. A minimum 5-min interval occurred between the first and second doses of nicorandil to reduce adverse effects. | Drug | Nicorandil |
| normal salineAll patients received antiplatelet agents (aspirin, ticagrelor) and heparin.Diagnostic coronary angiography (CAG) was performed via the right (or left) femoral artery or radial artery using the Seldinger method.The guidewire was passed into the culprit lesion. Normal saline in the Placebo Group were then given 2 ml through the lesions via thrombus aspiration catheter,and an additional intracoronary dose of 2 ml before stent implantation. A minimum 5-min interval occurred between the first and second injection. | Drug | normal saline |
Primary outcome
Primary composite endpoint (whether premature beats,atrial or ventricular tachycardia, atrial or ventricular fibrillation, and atrioventricular block appears;whether severity of chest pain is aggravated,and number of episodes chest pain)
Time frame: 24hours
The primary composite endpoint consisted of reperfusion-induced arrhythmia, worsening of chest pain, and no-reflow/slow reflow. In perioperative period,we will observe whether the reperfusion-induced arrhythmia including atrial or ventricular premature beats,atrial or ventricular tachycardia, atrial or ventricular fibrillation, and atrioventricular block appears;whether the severity of chest pain is aggravated,and the number of episodes of chest pain will be recorded for patients who complains of chest pain that lasted for at least 30 min within the 24 h following onset of MI;Whether the phenomenon of no-reflow/slow reflow appears.No-reflow and slow flow are diagnosed when the thrombolysis in myocardial infarction(TIMI) flow grade is 2 or lower,despite successful PCI such as balloon angioplasty or stent insertion.
1 secondary outcome
the combined outcome of TIMI frame count (cTFC) of CAG and ST resolution (STR) of ECG
Time frame: 24hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
- Background: PubMed 15823623Moens AL, Claeys MJ, Timmermans JP, Vrints CJ. Myocardial ischemia/reperfusion-injury, a clinical view on a complex pathophysiological process. Int J Cardiol. 2005 Apr 20;100(2):179-90. doi: 10.1016/j.ijcard.2004.04.013.
- Background: PubMed 11796561Reffelmann T, Kloner RA. The "no-reflow" phenomenon: basic science and clinical correlates. Heart. 2002 Feb;87(2):162-8. doi: 10.1136/heart.87.2.162. No abstract available.
- Background: PubMed 15261923Costantini CO, Stone GW, Mehran R, Aymong E, Grines CL, Cox DA, Stuckey T, Turco M, Gersh BJ, Tcheng JE, Garcia E, Griffin JJ, Guagliumi G, Leon MB, Lansky AJ. Frequency, correlates, and clinical implications of myocardial perfusion after primary angioplasty and stenting, with and without glycoprotein IIb/IIIa inhibition, in acute myocardial infarction. J Am Coll Cardiol. 2004 Jul 21;44(2):305-12. doi: 10.1016/j.jacc.2004.03.058.
- Background: PubMed 11994247Tanaka A, Kawarabayashi T, Nishibori Y, Sano T, Nishida Y, Fukuda D, Shimada K, Yoshikawa J. No-reflow phenomenon and lesion morphology in patients with acute myocardial infarction. Circulation. 2002 May 7;105(18):2148-52. doi: 10.1161/01.cir.0000015697.59592.07.
- Background: PubMed 16084155Limbruno U, De Carlo M, Pistolesi S, Micheli A, Petronio AS, Camacci T, Fontanini G, Balbarini A, Mariani M, De Caterina R. Distal embolization during primary angioplasty: histopathologic features and predictability. Am Heart J. 2005 Jul;150(1):102-8. doi: 10.1016/j.ahj.2005.01.016.
- Background: PubMed 22284272De Luca G, Navarese EP, Suryapranata H. A meta-analytic overview of thrombectomy during primary angioplasty. Int J Cardiol. 2013 Jul 1;166(3):606-12. doi: 10.1016/j.ijcard.2011.11.102. Epub 2012 Jan 28.
- Background: PubMed 12455077Werner GS, Lang K, Kuehnert H, Figulla HR. Intracoronary verapamil for reversal of no-reflow during coronary angioplasty for acute myocardial infarction. Catheter Cardiovasc Interv. 2002 Dec;57(4):444-51. doi: 10.1002/ccd.10375.
- Background: PubMed 10801755Marzilli M, Orsini E, Marraccini P, Testa R. Beneficial effects of intracoronary adenosine as an adjunct to primary angioplasty in acute myocardial infarction. Circulation. 2000 May 9;101(18):2154-9. doi: 10.1161/01.cir.101.18.2154.
- Background: PubMed 2525320Taira N. Nicorandil as a hybrid between nitrates and potassium channel activators. Am J Cardiol. 1989 Jun 20;63(21):18J-24J. doi: 10.1016/0002-9149(89)90200-2.
- Background: PubMed 16936418Ota S, Nishikawa H, Takeuchi M, Nakajima K, Nakamura T, Okamoto S, Setsuda M, Makino K, Yamakado T, Nakano T. Impact of nicorandil to prevent reperfusion injury in patients with acute myocardial infarction: Sigmart Multicenter Angioplasty Revascularization Trial (SMART). Circ J. 2006 Sep;70(9):1099-104. doi: 10.1253/circj.70.1099.
- Background: PubMed 12499617Tsubokawa A, Ueda K, Sakamoto H, Iwase T, Tamaki S. Effect of intracoronary nicorandil administration on preventing no-reflow/slow flow phenomenon during rotational atherectomy. Circ J. 2002 Dec;66(12):1119-23. doi: 10.1253/circj.66.1119.
- Background: PubMed 15459466Lim SY, Bae EH, Jeong MH, Kang DG, Lee YS, Kim KH, Lee SH, Yoon KH, Hong SN, Park HW, Hong YJ, Kim JH, Kim W, Ahn YK, Cho JG, Park JC, Kang JC. Effect of combined intracoronary adenosine and nicorandil on no-reflow phenomenon during percutaneous coronary intervention. Circ J. 2004 Oct;68(10):928-32. doi: 10.1253/circj.68.928.
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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.
Institute of Cardiovascular Disease Xuzhou Central Hospital study director
Southeast University
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 Nicorandil and normal saline in people with Coronary Heart Disease, run by Xuzhou Central 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 8 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 6 May 2015. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng chunguang, PhD (+8618936376559, fcg999@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary composite endpoint (whether premature beats,atrial or ventricular tachycardia, atrial or ventricular fibrillation, and atrioventricular block appears;whether severity of chest pain is aggravated,and number of episodes chest pain) (time frame: 24hours). 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 NCT02435797, which also lists 14 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 6 May 2015.