Effects of Optimized Antiplatelet Treatment After Percutaneous Coronary Intervention - Full Text View

Sponsor:	Shenyang Northern Hospital
Information provided by:	Shenyang Northern Hospital
ClinicalTrials.gov Identifier:	NCT00404781

Purpose

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.

Condition	Intervention	Phase
Ischemic Heart Disease Acute Coronary Syndromes	Drug: cilostazol in addition to aspirin and clopidogrel	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Pilot Study of Personal Optimized Antiplatelet Treatment After Percutaneous Coronary Intervention in Patients With Acute Coronary Syndromes

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Heart Diseases

Drug Information available for: Acetylsalicylic acid Cilostazol Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Further study details as provided by Shenyang Northern Hospital:

Primary Outcome Measures:

Major adverse cardiac and cerebral events at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Hemorrhage events at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment:	305
Study Start Date:	June 2006
Study Completion Date:	June 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: optimal antiplatelet cilostazol in addition to aspirin and clopdidogrel for pts with clopidogrel resistance	Drug: cilostazol in addition to aspirin and clopidogrel
Active Comparator: standard antiplatelet aspirin and clopidogrel for all patients	Drug: cilostazol in addition to aspirin and clopidogrel

Eligibility

Ages Eligible for Study:	35 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404781

Locations

China, Liaoning
Northern Hospital
Shenyang, Liaoning, China, 110016

Sponsors and Collaborators

Shenyang Northern Hospital

Investigators

Principal Investigator:

Yaling Han, M.D.

Shenyang Northern Hospital

More Information

No publications provided

Responsible Party:	Yaling Han, Shenyang Northern Hospital
ClinicalTrials.gov Identifier:	NCT00404781 History of Changes
Other Study ID Numbers:	NH-2006-C001
Study First Received:	November 28, 2006
Last Updated:	October 13, 2009
Health Authority:	China: Ministry of Health

Keywords provided by Shenyang Northern Hospital:

ischemic heart disease
acute coronary syndromes
percutaneous transluminal coronary angioplasty
platelet function

aspirin
clopidogrel
cilostazol

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Ischemia
Acute Coronary Syndrome
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

Aspirin
Cilostazol
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents

ClinicalTrials.gov processed this record on February 09, 2012