ACCEL-LOADING-ACS Study
Recruitment status was Recruiting
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Platelet Aggregation Inhibitors Anti-inflammatory Agent Myocardial Reperfusion Injury |
Drug: Dual Anti-Platelet Therapy (DAPT) Drug: Triple Anti-Platelet Therapy (TAPT) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | ACCELerated Inhibition of Platelet Aggregation, Inflammation and Ischemia-reperfusion Injury by Adjunctive Cilostazol Loading in Patients With Acute Coronary Syndrome |
- Major adverse cardiovascular events (MACE) [ Time Frame: 1 month ] [ Designated as safety issue: No ]Composite of cardiac death, MI and ischemia-driven target lesion revascularization (TLR)
- P2Y12 reaction unit levels in the 2 arms [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- MACE incidence according to P2Y12 reaction unit [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- any post-procedural increase of markers of myocardial injury above ULN [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- post-procedural variations from baseline of hs-CRP levels in the 2 arms [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- ACUITY major/minor bleeding rate [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- 24hr post-procedural variations from baseline of inflammation markers (IL-6, TNF-alpha, cell adhesion molecules (VCAM, ICAM, E-selectin) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 220 |
| Study Start Date: | July 2010 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: DAPT |
Drug: Dual Anti-Platelet Therapy (DAPT)
|
| Experimental: TAPT |
Drug: Triple Anti-Platelet Therapy (TAPT)
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- at least 18 years of age
- Non-ST-elevation ACS patients undergoing PCI within 48 hours after hospitalization
Exclusion Criteria:
- 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
- Left ventricular ejection fraction < 30%
- WBC < 3,000/mm3, platelet < 100,000/mm3
- Creatinine ≥ 3 mg/dl
- stroke within 3 months
Contacts and Locations| Contact: Young-Hoon Jeong, MD, PhD | 410-830-1628 | goodoctor@naver.com |
| Contact: Yongwhi Park, MD, PhD | 82-55-750-8873 | angio2000@hanmail.net |
| Korea, Republic of | |
| Gyeonsang National University Hospital | Recruiting |
| Jinju, Gyeonsangnam-do, Korea, Republic of, 660-702 | |
| Contact: Young-Hoon Jeong, MD, PhD 410-830-1628 goodoctor@naver.com | |
| Contact: Yongwhi Park, MD, PhD 82-55-750-8873 angio2000@hanmail.net | |
| Principal Investigator: Young-Hoon Jeong, MD, PhD | |
| Principal Investigator: | Kyounghoon Lee, MD, PhD | Gil hospital |
| Principal Investigator: | Jae-Hyeong Park, MD, PhD | Chungnam National University Hospital |
| Principal Investigator: | Keun-Ho Park, MD | Heart Center of Chonnam National University Hospital |
| Principal Investigator: | Jon Suh, MD, PhD | Soon Chun Hyang University Bucheon Hospital |
| Principal Investigator: | Sang-Yong Yoo, MD, PhD | Gangneung Asan Medical Center |
More Information
Publications:
| Responsible Party: | Gyeongsang National University Hospital, Clinical Science Investigation Office |
| ClinicalTrials.gov Identifier: | NCT01354808 History of Changes |
| Other Study ID Numbers: | ACCEL-LOADING |
| Study First Received: | May 15, 2011 |
| Last Updated: | May 16, 2011 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Gyeongsang National University Hospital:
|
Cilostazol Platelet Inflammation Myonecrosis |
Additional relevant MeSH terms:
|
Inflammation Myocardial Reperfusion Injury Reperfusion Injury Acute Coronary Syndrome Pathologic Processes Cardiomyopathies Heart Diseases Cardiovascular Diseases Myocardial Ischemia Vascular Diseases Postoperative Complications Angina Pectoris Chest Pain Pain Signs and Symptoms |
Cilostazol Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Hematologic Agents Platelet Aggregation Inhibitors Vasodilator Agents Neuroprotective Agents Protective Agents Physiological Effects of Drugs Central Nervous System Agents Phosphodiesterase 3 Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013