Study to Learn When Platelets Return to Normal After One Loading Dose of Anti-platelet Drugs in Patients With Symptoms of Acute Coronary Syndromes

Lilly

Status and phase

Terminated

Phase 1

Conditions

Acute Coronary Syndromes

Treatments

Drug: prasugrel

Drug: clopidogrel

Study type

Interventional

Funder types

Industry

Identifiers

NCT01107899

11983

H7T-MC-TACM (Other Identifier)

Details and patient eligibility

About

To investigate how platelets recover to normal function in subjects who have symptoms of a heart attack or unstable angina and who get a loading dose of prasugrel or clopidogrel for planned coronary angiography.

Enrollment

29 patients

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Men or women ≥18 to <80 years of age who present with any one of the following:
symptoms of Acute Coronary Syndromes (ACS)
clinical symptoms of angina, or a positive stress test or who return for routine follow up angiography post stent placement in whom co-administration of aspirin and a thienopyridine (that is, clopidogrel, ticlopidine, or prasugrel) is not contraindicated

Exclusion criteria

Those presenting with ST-elevation MI (STEMI)
histories of refractory ventricular arrhythmias
an implanted defibrillator device
congestive heart failure (NYHA Class III or above) within 6 months prior to screening
significant hypertension
subjects with a history or clinical suspicion of cerebral vascular malformations, transient ischaemic attack, or stroke
bleeding disorders
women known to be pregnant, who have given birth within the past 90 days, or who are breastfeeding