Efficacy and Safety of Adjunctive Cilostazol in Acute Myocardial Infarction Patients

NCT01261832 | Unknown Phase 4 DMC

• 1 other identifier: KoreaUGuroH SILOAM
• Study Type: interventional
• Target: 951
• Locations: 1 country
• Sites: 1

Brief Summary

Current antiplatelet therapy in acute coronary syndrome have a focus on the dual antiplatelet therapy including aspirin and clopidogrel. However, the patient's drug resistance of aspirin and clopidogrel is the important cause of poor clinical prognosis. Therefore, recently, clinical research about the triple antiplatelet therapy including cilostazol is actively conducted. But, clinical research about triple antiplatelet therapy for acute myocardial infarction is inadequate situation, and the ideal duration of triple antiplatelet therapy has been actively discussed. Therefore, we try to evaluate the clinical outcomes of triple antiplatelet therapy in acute myocardial infarction patients undergoing percutaneous intervention with drug eluting stent compared with dual antiplatelet therapy and investigate ideal duration of triple antiplatelet therapy through this research.

Conditions

Acute Myocardial Infarction

Keywords

Acute Myocardial Infarction; Percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiovascular and Cerebral Events

  Composite of total death, Nonfatal Myocardial Infarction (Non-QMI , Q-MI), Repeat RevascularizationI (Target Vessel Revascularization +Non Target Vessel Revascularization , Coronary Artery Bypass Graft), Stroke (Ischemic \& Hemorrhagic)

  One Year

Secondary Outcomes (1)

• Individual outcome of primary end points, Stent thrombosis,Bleeding Complication,PFT (Platelet function test),Genotyping results

  One year

Study Arms (3)

Dual antiplatelet therapy for 1 year

EXPERIMENTAL

Dual antiplatelet therapy for 1 year : dual antiplatelet combination therapy with aspirin and clopidogrel for 1 year

Drug: antiplatelet therapy

Triple antiplatelet therapy for 1 month

EXPERIMENTAL

Triple antiplatelet therapy for 1 month : triple antiplatelet therapy including cilostazol for 1 month and after then, dual antiplatelet therapy for 11 months

Drug: antiplatelet therapy

Triple antiplatelet therapy for 6 months

EXPERIMENTAL

Triple antiplatelet therapy for 6 months : triple antiplatelet combination therapy including cilostazol for 6 months and after then, dual antiplatelet therapy for 6 months and cilostazol

Drug: antiplatelet therapy

Interventions

antiplatelet therapy DRUG

Dual antiplatelet therapy is defined as combination therapy with aspirin and clopidogrel and triple antiplatelet therapy is defined as combination therapy with aspirin,clopidogrel and cilostazol.

Also known as: The brand name of clopidogrel is Plavix., The brand name of cilostazol is Pletaal.

Dual antiplatelet therapy for 1 year; Triple antiplatelet therapy for 1 month; Triple antiplatelet therapy for 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Cilostazol
• Uncontrolled hypertension
• History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or refuses blood transfusions.
• Baseline hemogram with Hb\<10g/dL or PLT count\<100,000/μL
• Patients already taking warfarin, cilostazol or any other type of anti-platelet agents except aspirin and clopidogrel
• Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
• Pregnancy

Sponsors & Collaborators

• Korea University Guro Hospital: lead

Study Sites (1)

Korea University Guro Hospital

Seoul, South Korea

Location

Related Publications (1)

• Chen KY, Rha SW, Li YJ, Poddar KL, Jin Z, Minami Y, Wang L, Kim EJ, Park CG, Seo HS, Oh DJ, Jeong MH, Ahn YK, Hong TJ, Kim YJ, Hur SH, Seong IW, Chae JK, Cho MC, Bae JH, Choi DH, Jang YS, Chae IH, Kim CJ, Yoon JH, Chung WS, Seung KB, Park SJ; Korea Acute Myocardial Infarction Registry Investigators. Triple versus dual antiplatelet therapy in patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention. Circulation. 2009 Jun 30;119(25):3207-14. doi: 10.1161/CIRCULATIONAHA.108.822791. Epub 2009 Jun 15.

  PMID: 19528339 BACKGROUND

Study Officials

• Seung Woon Rha, MD. PhD.

  Cardiovascular Center, Korea University Guro Hospital, 80, Guro-dong, Guro-gu, Seoul, 152-703, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 16, 2010
• First Posted: December 17, 2010
• Study Start: July 1, 2011
• Primary Completion: February 1, 2020
• Study Completion: March 1, 2022
• Last Updated: February 20, 2020

Record last verified: 2020-02

Locations

KR (1)