Platelet Inhibition in Patients With Systolic Heart Failure

• Status: Completed
• Trial end date: 2015-12-28
• Target enrollment: 0
• Participant gender: All

Summary

The investigators aim to determine if patients with systolic heart failure treated with prasugrel achieve greater platelet inhibition compared to those treated with clopidogrel.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Nebraska
• Collaborators: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.; Eli Lilly and Company
• Treatments: Clopidogrel; Prasugrel Hydrochloride; Ticlopidine

Criteria

Inclusion Criteria:

• Patients 19 to 74 years of age.

• Patients with a left ventricular ejection fraction <35% by echocardiogram, SPECT myocardial perfusion study, cardiac MRI, cardiac computerized tomographic angiogram or invasive left ventricular angiogram within the last 6 months.

• Patients with NYHA Class III-IV heart failure at the time of enrollment.

Exclusion Criteria:

• Recent hospitalization within 30 days

• Patients expected to undergo major surgery or PCI in the next 30 days

• Patients taking clopidogrel, prasugrel, ticagrelor, ticlopidine, or cilostazol

• Patients listed for heart transplantation or having left ventricular assist device placement

• Patients with known allergy to either medication

• Patients with prior history of stroke or transient ischemic attack

• Patients with known intracranial neoplasm, aneurysm, or arteriovenous malformation

• Patients with a history of bleeding requiring hospitalization for treatment

• Patients taking oral anticoagulants

• Patients with body weight <60 kg

• Women who are pregnant or breastfeeding

• Patients with hemoglobin <10 mg/dl or platelet count <100,000/ul at baseline

• Patients with known clotting or platelet disorders

• Patients with a baseline INR > 1.4

• Patients with liver function tests (AST or ALT) > 2 times normal

• Patients with a suspected change in their use of aspirin during the study (starting, stopping, or changing dose of aspirin)

• Patients unwilling to consent to CYP2C19 genetic testing.