Platelet Aggregation InhibitorsPhase 4NCT01354808
ACCEL-LOADING-ACS Study
A Phase 4 study testing Dual Anti-Platelet Therapy (DAPT) and Triple Anti-Platelet Therapy (TAPT) in people with Platelet Aggregation Inhibitors and Anti-inflammatory Agent, run by Gyeongsang National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether adjunctive cilostazol loading/maintenance to standard treatment (aspirin, clopidogrel, and statin) is effective in reduction of major adverse cardiovascular events, platelet activation, inflammation and myonecrosis in patients with non-ST-elevation acute coronary… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Platelet Aggregation Inhibitors, Anti-inflammatory Agent, Myocardial Reperfusion Injury
- What is being tested?
- Dual Anti-Platelet Therapy (DAPT) and Triple Anti-Platelet Therapy (TAPT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2010to Jul 2012
- 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
- at least 18 years of age
- Non-ST-elevation ACS patients undergoing PCI within 48 hours after hospitalization
Who cannot join
- ST segment elevation acute myocardial infarction
- NSTE ACS with high-risk features warranting emergency coronary angiography
- Oral anticoagulation therapy with warfarin
- Use of pre-procedural glycoprotein IIb/IIIa inhibitor
- Contraindication to antiplatelet therapy
- AST or ALT ≥ 3 times upper normal
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- Left ventricular ejection fraction < 30%
- WBC < 3,000/mm3, platelet < 100,000/mm3
- Creatinine ≥ 3 mg/dl
- stroke within 3 months
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Gyeonsang National University Hospital
Jinju, Gyeonsangnam-do, 660-702
About this study
Official title: ACCELerated Inhibition of Platelet Aggregation, Inflammation and Ischemia-reperfusion Injury by Adjunctive Cilostazol Loading in Patients With Acute Coronary Syndrome
The purpose of this study is to determine whether adjunctive cilostazol loading/maintenance to standard treatment (aspirin, clopidogrel, and statin) is effective in reduction of major adverse cardiovascular events, platelet activation, inflammation and myonecrosis in patients with non-ST-elevation acute coronary syndrome (ACS)undergoing percutaneous coronary intervention (PCI).
Read the detailed description
In ACS patients, platelet activation, inflammation, and ischemia-reperfusion injury can be closely associated with the risk of post-PCI myonecrosis and ischemic events occurrence. In the ACCEL-AMI (Adjunctive Cilostazol versus high maintenance-dose ClopidogrEL in patients with Acute Myocardial Infarction)study, adjunctive cilostazol increased platelet inhibition compared with double-dose clopidogrel. Meanwhile, statins can reduce the extent of myonecrosis via limiting inflammation and myocardial infarct size by activating phosphatidylinositol-3-kinase (PI3K), ecto-5'-nucleotidase, Akt/endothelial nitric oxide synthase (eNOS), and the downstream effectors inducible nitric oxide synthase (iNOS) and cyclooxygenase-2 (COX-2). Inhibition of PI3K, adenosine receptors, eNOS, iNOS, or COX-2 abrogates the protective effects of statins. In animal study, the combination of low-dose statin with cilostazol synergistically limits infarct size. Multiple studies have shown that cilostazol can influence inflammation and RISK pathway using the similar pathway with statin. This study will be performed to evaluate the role of adjunctive cilostazol in platelet inhibition, inflammation, and myonecrosis compared with standard treatment.
- Being tested
- Dual Anti-Platelet Therapy (DAPT), Triple Anti-Platelet Therapy (TAPT)
- Keywords
- Cilostazol, Platelet, Inflammation, Myonecrosis
- Medical subject headings
- Myocardial Reperfusion Injury, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual Anti-Platelet Therapy (DAPT)Drug
- Loading: aspirin 300mg + clopidogrel 600mg
- Maintenance: aspirin 200mg/d + clopidogrel 75mg/d for 1 month
Triple Anti-Platelet Therapy (TAPT)Drug
- Loading: cilostazol 200mg + aspirin 300mg + clopidogrel 600mg
- Maintenance: cilostazol 100mg bid+ aspirin 200mg/d+ clopidogrel 75mg/d for 1 month
| Study group | Role | What they receive |
|---|---|---|
| DAPT | Active comparator | Not described Receives: Drug: Dual Anti-Platelet Therapy (DAPT) |
| TAPT | Experimental | Not described Receives: Drug: Triple Anti-Platelet Therapy (TAPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events (MACE)
Composite of cardiac death, MI and ischemia-driven target lesion revascularization (TLR)
Measured: 1 month
Secondary outcomes (6)
P2Y12 reaction unit levels in the 2 arms
Measured: 1 month
MACE incidence according to P2Y12 reaction unit
Measured: 1 month
any post-procedural increase of markers of myocardial injury above ULN
Measured: 1 month
post-procedural variations from baseline of hs-CRP levels in the 2 arms
Measured: 1 month
ACUITY major/minor bleeding rate
Measured: 1 month
24hr post-procedural variations from baseline of inflammation markers (IL-6, TNF-alpha, cell adhesion molecules (VCAM, ICAM, E-selectin)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2011 (estimated)
- Study startJul 2010
- Primary completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Platelet Aggregation InhibitorsStudies 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
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gyeongsang National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyounghoon Lee, MD, PhD, Principal investigator, Gil hospitalJae-Hyeong Park, MD, PhD, Principal investigator, Chungnam National University HospitalKeun-Ho Park, MD, Principal investigator, Heart Center of Chonnam National University HospitalJon Suh, MD, PhD, Principal investigator, Soon Chun Hyang UniversitySang-Yong Yoo, MD, PhD, Principal investigator, Gangneung Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354808
- Sponsor's protocol ID
- ACCEL-LOADING
- Status last verified
- Sep 2013
- First submitted
- 15 May 2011
- Last updated
- 24 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Patti G, Pasceri V, Colonna G, Miglionico M, Fischetti D, Sardella G, Montinaro A, Di Sciascio G. Atorvastatin pretreatment improves outcomes in patients with acute coronary syndromes undergoing early percutaneous coronary intervention: results of the ARMYDA-ACS randomized trial. J Am Coll Cardiol. 2007 Mar 27;49(12):1272-8. doi: 10.1016/j.jacc.2007.02.025.
PubMed 17394957Jeong YH, Hwang JY, Kim IS, Park Y, Hwang SJ, Lee SW, Kwak CH, Park SW. Adding cilostazol to dual antiplatelet therapy achieves greater platelet inhibition than high maintenance dose clopidogrel in patients with acute myocardial infarction: Results of the adjunctive cilostazol versus high maintenance dose clopidogrel in patients with AMI (ACCEL-AMI) study. Circ Cardiovasc Interv. 2010 Feb 1;3(1):17-26. doi: 10.1161/CIRCINTERVENTIONS.109.880179. Epub 2010 Jan 26.
PubMed 20118150
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACCELerated Inhibition of Platelet Aggregation, Inflammation and Ischemia-reperfusion Injury by Adjunctive Cilostazol Loading in Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT01354808
- Acronym / sponsor ID
- ACCEL-LOADING
- Keywords
- Cilostazol, Platelet, Inflammation, Myonecrosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Gyeongsang National University HospitalUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2012 (actual)
- First posted
- 17 May 2011 (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.
The purpose of this study is to determine whether adjunctive cilostazol loading/maintenance to standard treatment (aspirin, clopidogrel, and statin) is effective in reduction of major adverse cardiovascular events, platelet activation, inflammation and myonecrosis in patients with non-ST-elevation acute coronary syndrome (ACS)undergoing percutaneous coronary intervention (PCI).
Detailed description
In ACS patients, platelet activation, inflammation, and ischemia-reperfusion injury can be closely associated with the risk of post-PCI myonecrosis and ischemic events occurrence. In the ACCEL-AMI (Adjunctive Cilostazol versus high maintenance-dose ClopidogrEL in patients with Acute Myocardial Infarction)study, adjunctive cilostazol increased platelet inhibition compared with double-dose clopidogrel. Meanwhile, statins can reduce the extent of myonecrosis via limiting inflammation and myocardial infarct size by activating phosphatidylinositol-3-kinase (PI3K), ecto-5'-nucleotidase, Akt/endothelial nitric oxide synthase (eNOS), and the downstream effectors inducible nitric oxide synthase (iNOS) and cyclooxygenase-2 (COX-2). Inhibition of PI3K, adenosine receptors, eNOS, iNOS, or COX-2 abrogates the protective effects of statins. In animal study, the combination of low-dose statin with cilostazol synergistically limits infarct size. Multiple studies have shown that cilostazol can influence inflammation and RISK pathway using the similar pathway with statin. This study will be performed to evaluate the role of adjunctive cilostazol in platelet inhibition, inflammation, and myonecrosis compared with standard treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DAPT | Active comparator | Drug: Dual Anti-Platelet Therapy (DAPT) |
| TAPT | Experimental | Drug: Triple Anti-Platelet Therapy (TAPT) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- at least 18 years of age
- Non-ST-elevation ACS patients undergoing PCI within 48 hours after hospitalization
Key exclusion criteria (10 listed)
- ST segment elevation acute myocardial infarction
- NSTE ACS with high-risk features warranting emergency coronary angiography
- Oral anticoagulation therapy with warfarin
- Use of pre-procedural glycoprotein IIb/IIIa inhibitor
- Contraindication to antiplatelet therapy
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 |
|---|---|---|
| Dual Anti-Platelet Therapy (DAPT)* Loading: aspirin 300mg + clopidogrel 600mg * Maintenance: aspirin 200mg/d + clopidogrel 75mg/d for 1 month | Drug | DAPT |
| Triple Anti-Platelet Therapy (TAPT)* Loading: cilostazol 200mg + aspirin 300mg + clopidogrel 600mg * Maintenance: cilostazol 100mg bid+ aspirin 200mg/d+ clopidogrel 75mg/d for 1 month | Drug | TAPT |
Primary outcome
Major adverse cardiovascular events (MACE)
Time frame: 1 month
Composite of cardiac death, MI and ischemia-driven target lesion revascularization (TLR)
6 secondary outcomes
P2Y12 reaction unit levels in the 2 arms
Time frame: 1 month
MACE incidence according to P2Y12 reaction unit
Time frame: 1 month
any post-procedural increase of markers of myocardial injury above ULN
Time frame: 1 month
post-procedural variations from baseline of hs-CRP levels in the 2 arms
Time frame: 1 month
ACUITY major/minor bleeding rate
Time frame: 1 month
24hr post-procedural variations from baseline of inflammation markers (IL-6, TNF-alpha, cell adhesion molecules (VCAM, ICAM, E-selectin)
Time frame: 1 month
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 24 Sep 2013.
- Results publication: PubMed 17394957Patti G, Pasceri V, Colonna G, Miglionico M, Fischetti D, Sardella G, Montinaro A, Di Sciascio G. Atorvastatin pretreatment improves outcomes in patients with acute coronary syndromes undergoing early percutaneous coronary intervention: results of the ARMYDA-ACS randomized trial. J Am Coll Cardiol. 2007 Mar 27;49(12):1272-8. doi: 10.1016/j.jacc.2007.02.025.
- Results publication: PubMed 20118150Jeong YH, Hwang JY, Kim IS, Park Y, Hwang SJ, Lee SW, Kwak CH, Park SW. Adding cilostazol to dual antiplatelet therapy achieves greater platelet inhibition than high maintenance dose clopidogrel in patients with acute myocardial infarction: Results of the adjunctive cilostazol versus high maintenance dose clopidogrel in patients with AMI (ACCEL-AMI) study. Circ Cardiovasc Interv. 2010 Feb 1;3(1):17-26. doi: 10.1161/CIRCINTERVENTIONS.109.880179. Epub 2010 Jan 26.
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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.
Kyounghoon Lee, MD, PhD principal investigator
Gil hospital
Jae-Hyeong Park, MD, PhD principal investigator
Chungnam National University Hospital
Keun-Ho Park, MD principal investigator
Heart Center of Chonnam National University Hospital
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 Dual Anti-Platelet Therapy (DAPT) and Triple Anti-Platelet Therapy (TAPT) in people with Platelet Aggregation Inhibitors and Anti-inflammatory Agent, run by Gyeongsang National University Hospital at 1 site in South Korea.
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 2 inclusion and 10 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 24 Sep 2013. 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 South Korea. 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?
Major adverse cardiovascular events (MACE) (time frame: 1 month). 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 NCT01354808, which also lists 2 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 24 Sep 2013.