Effects of Optimized Antiplatelet Treatment After Percutaneous Coronary Intervention

NCT00404781 | Completed Phase 4 DMC

• 1 other identifier: NH-2006-C001
• Study Type: interventional
• Target: 305
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic Heart Disease; Acute Coronary Syndromes

Keywords

ischemic heart disease; acute coronary syndromes; percutaneous transluminal coronary angioplasty; platelet function; aspirin; clopidogrel; cilostazol

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiac and cerebral events at 1 year

  1 year

Secondary Outcomes (1)

• Hemorrhage events at 1 year

  1 year

Study Arms (2)

optimal antiplatelet

EXPERIMENTAL

cilostazol in addition to aspirin and clopdidogrel for pts with clopidogrel resistance

Drug: cilostazol in addition to aspirin and clopidogrel

standard antiplatelet

ACTIVE COMPARATOR

aspirin and clopidogrel for all patients

Drug: cilostazol in addition to aspirin and clopidogrel

Interventions

cilostazol in addition to aspirin and clopidogrel DRUG

optimal antiplatelet; standard antiplatelet

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• non-ST-segment elevated acute coronary syndromes
• patients undergoing selective or emergent PCI

You may not qualify if:

• 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

Sponsors & Collaborators

• Shenyang Northern Hospital: lead

Study Sites (1)

Northern Hospital

Shenyang, Liaoning, 110016, China

Location

MeSH Terms

Conditions

Myocardial Ischemia; Acute Coronary Syndrome

Interventions

Cilostazol; Clopidogrel

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines

Study Officials

• Yaling Han, M.D.

  Shenyang Northern Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 28, 2006
• First Posted: November 29, 2006
• Study Start: June 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: October 14, 2009

Record last verified: 2009-10

Locations

CN (1)