Prasugrel in comparison to Clopidogrel for Inhibition of Platelet Activation and Aggregation (PRINCIPLE) - TIMI 44 - Principle -TIMI 44

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 180

Inclusion Criteria

[1] Subjects =18 years of age undergoing cardiac catheterization with planned percutaneous coronary intervention (if coronary anatomy is suitable) for an indication of chest pain +/or anginal equivalent felt by the treating physician to be related to coronary ischemia.
[2] At least one of the following (a through c):
a) Functional study (exercise, or pharmacologic) within the past 8 weeks consistent with ischemia as manifested by at least one of the following:
1. A reversible defect on nuclear imaging.
2. A reversible wall-motion abnormality by echocardiography.
3. Horizontal or down-sloping ST-depressions >1 mm on electrocardiogram (ECG) (if no imaging performed).
b) Prior coronary revascularization [percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)].
c) A cardiac catheterization with at least one coronary artery lesion amenable to PCI (not yet performed) within 14 days prior to enrollment.

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

Cardiovascular Exclusion Criteria
[1] Known creatine kinase-myocardial bands (CK-MB) or cardiac troponin greater than the upper limit of normal (ULN) at the time of screening.
[2] Have a planned PCI procedure as initial treatment for an acute myocardial infarction (MI) (STEMI or NSTEMI), or a planned PCI within 48 hours of fibrinolytic therapy for STEMI.
[3] Have cardiogenic shock at the time of screening (systolic blood pressure <90 mm Hg associated with clinical evidence of end-organ hypoperfusion, or subjects requiring vasopressors to maintain systolic blood pressure over 90 mm Hg and associated with clinical evidence of end-organ hypoperfusion).
[4] Have refractory ventricular arrhythmias.
[5] Have New York Heart Association (NYHA) Class IV congestive heart failure (CHF) (see Attachment 4 for NYHA CHF classifications).
Bleeding Risk Exclusion Criteria
[6] Have active internal bleeding or history of bleeding diathesis.
[7] Have clinical findings, in the judgment of the investigator, associated with an increased risk of bleeding.
[8] 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.
[9] Have an International Normalized Ratio (INR) known to be >1.5 at the time of screening.
[10] Have a platelet count of <100,000/mm3 at the time of screening.
[11] Have anemia (hemoglobin [Hgb] <10 gm/dL) at the time of screening.
Prior/Concomitant Therapy Exclusion Criteria
[12] Have received one or more doses of a thienopyridine (ticlopidine or clopidogrel) =5 days prior to PCI.
[13] Have been administered a GPIIb/IIIa inhibitor within the past 7 days or plans to use a GPIIb/IIIa inhibitor during PCI.
[14] Are receiving or will receive oral anticoagulation or oral antiplatelet therapy (other than aspirin) that cannot be safely discontinued for the duration of the study.
[15] Are receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (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
[16] Are investigative site personnel directly affiliated with the study or are immediate family of investigative site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
[17] Are employed by Eli Lilly & Company, Ube Industries Limited, Daiichi Sankyo Company Limited, The TIMI Study Group, or the contract research organization (CRO) (that is, employees, temporary contract workers, or designees responsible for the conduct of the study). Immediate family of Lilly employees may participate in Lilly sponsored
clinical studies but are not permitted to participate at a Lilly facility. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
[18] Have received treatment within the last 30 days with a drug or device that has not received regulatory approval for any indication at the time of study entry or are presently enrolled in another drug or device study.
[19] Have previously completed or withdrawn from this study or any other study investigating prasugrel.
[20] Are women who are known to be pregnant, who have given birth within the past 90 days, who are breastfeeding, or of child-bearing potential who test negative for pregnancy

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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