ACCEL-LOADING-ACS Study
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ClinicalTrials.gov Identifier: NCT01354808 |
Recruitment Status :
Completed
First Posted : May 17, 2011
Last Update Posted : September 24, 2013
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Condition or disease | Intervention/treatment | Phase |
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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 (Clinical Trial) |
Estimated Enrollment : | 220 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | July 2010 |
Actual Primary Completion Date : | July 2012 |
Arm | Intervention/treatment |
---|---|
Active Comparator: DAPT |
Drug: Dual Anti-Platelet Therapy (DAPT)
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Experimental: TAPT |
Drug: Triple Anti-Platelet Therapy (TAPT)
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- Major adverse cardiovascular events (MACE) [ Time Frame: 1 month ]Composite of cardiac death, MI and ischemia-driven target lesion revascularization (TLR)
- 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 ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01354808
Korea, Republic of | |
Gyeonsang National University Hospital | |
Jinju, Gyeonsangnam-do, Korea, Republic of, 660-702 |
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 | |
Principal Investigator: | Sang-Yong Yoo, MD, PhD | Gangneung Asan Medical Center |
Responsible Party: | Gyeongsang National University Hospital |
ClinicalTrials.gov Identifier: | NCT01354808 |
Other Study ID Numbers: |
ACCEL-LOADING |
First Posted: | May 17, 2011 Key Record Dates |
Last Update Posted: | September 24, 2013 |
Last Verified: | September 2013 |
Cilostazol Platelet Inflammation Myonecrosis |
Reperfusion Injury Myocardial Reperfusion Injury Vascular Diseases Cardiovascular Diseases Postoperative Complications |
Pathologic Processes Cardiomyopathies Heart Diseases Myocardial Ischemia |