A Comparison of CS-747 and Clopidogrel in Acute Coronary Syndrome Subjects who are to Undergo Percutaneous Coronary Intervention - TRITON; TIMI 38; TAA

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 14500

Inclusion Criteria

Subjects are eligible to be included in the study only if they meet all of the following
criteria:
[1] Present with acute coronary syndrome based on the disease
diagnostic criteria and are to undergo percutaneous coronary
intervention (PCI).
[2] Are of a legal age (and at least 18 years of age) and competent mental
condition to provide written informed consent before entering the
study. Informed consent must be signed by the study participant or
authorized representative, according to local rules and regulations.
[3] For women of child-bearing potential only (that is, women who are not
surgically or chemically sterilized and who are between menarche and
1 year postmenopause), test negative for pregnancy between ACS
presentation and enrollment (based on a urine or serum pregnancy test)
and agree to use a reliable method of birth control during the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects will be excluded from the study if they meet any of the following criteria:
Cardiovascular Exclusion Criteria
[4] Have cardiogenic shock
[5] Have refractory ventricular arrhythmias.
[6] Have NYHA Class IV congestive heart failure
Bleeding Risk Exclusion Criteria
[7] Have received fibrin-specific fibrinolytic therapy <24 hours prior to randomization.
[8] Have received nonfibrin-specific fibrinolytic therapy <48 hours prior to randomization.
[9] Have active internal bleeding or history of bleeding diathesis.
[10] Have clinical findings, in the judgment of the investigator, associated with an increased risk of bleeding.
[11] Have any of the following:
a) Prior history of hemorrhagic stroke.
b) Intracranial neoplasm, arteriovenous malformation, or aneurysm.
c) Ischemic stroke =<3 months prior to screening.
[12] Have an INR known to be >1.5 at the time of evaluation.
[13] Have a platelet count of <100,000/mm3 at the time of screening.
[14] Have anemia (hemoglobin <10 g/dL) at the time of screening.
Prior/Concomitant Therapy Exclusion Criteria
[15] Have received one or more doses of a thienopyridine =<5 days prior to PCI.
[16] Are receiving or will receive oral anticoagulation or other antiplatelet therapy that cannot be safely discontinued for the duration of the study.
[17] Are receiving daily treatment with NSAIDs or COX2 inhibitors that cannot be discontinued or are anticipated to require >2 weeks of daily treatment with NSAID or COX2 inhibitors during the study.
General Exclusion Criteria
[21] Have previously completed or withdrawn from this study or any other
study investigating CS-747.
[22] Are women who are known to be pregnant, who have given birth within the past 90 days, or who are breastfeeding.
[23] Have a concomitant medical illness (for example, terminal malignancy) that in the opinion of the investigator is associated with reduced survival over the expected treatment period (maximum of 15 months).
[24] Have known severe hepatic dysfunction (i.e. cirrhosis or portal hypertension).
[25] Have a condition associated with poor treatment compliance, including alcoholism, mental illness, or drug dependence.
[26] Have a history of intolerance or allergy to aspirin or approved thienopyridines (ticlopidine or clopidogrel).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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