Effects of Optimized Antiplatelet Treatment After Percutaneous Coronary Intervention

Ischemic Heart Disease Clinical Trial

Official title:

Pilot Study of Personal Optimized Antiplatelet Treatment After Percutaneous Coronary Intervention in Patients With Acute Coronary Syndromes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00404781
• Other study ID #: NH-2006-C001
• Status: Completed
• Phase: Phase 4
• First received: November 28, 2006
• Last updated: October 13, 2009
• Start date: June 2006
• Est. completion date: June 2007

Study information

• Verified date: October 2009
• Source: Shenyang Northern Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Effects of dual antiplatelet therapy with aspirin and clopidogrel after percutaneous coronary intervention has been proven. However, patients with low response to those agents are reported be associated with adverse clinical outcomes. We suppose that optimized antiplatelet therapy for individual patients based on platelet function assay may improve long-term outcomes especially in patients with high risk of thrombosis. In this prospective randomized study, patients in control group all receive standard dual antiplatelet therapy, and patients in optimized group receive different antiplatelet therapy according to risk stratification.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 305
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

Inclusion Criteria:

• non-ST-segment elevated acute coronary syndromes

• patients undergoing selective or emergent PCI

Exclusion Criteria:

• administration of clopidogrel or ticlopidine within 2 weeks

• ST-segment elevated myocardial infarction

• contraindications of antiplatelet therapy

• history of intracranial bleeding

• known bleeding disorders

• severe liver or kidney disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes
• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Drug:
• cilostazol in addition to aspirin and clopidogrel

Locations

Country	Name	City	State
China	Northern Hospital	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shenyang Northern Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac and cerebral events at 1 year		1 year	No
Secondary	Hemorrhage events at 1 year		1 year	Yes