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

NCT ID: NCT01107899

Last Updated: 2012-03-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-12-31

Brief Summary

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.

Conditions

Acute Coronary Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

clopidogrel 600 mg

Group Type: ACTIVE_COMPARATOR

clopidogrel

Intervention Type: DRUG

taken orally, day one, single dose

prasugrel 60 mg

Group Type: ACTIVE_COMPARATOR

prasugrel

Intervention Type: DRUG

taken orally, day one, single dose

prasugrel 30 mg

Group Type: EXPERIMENTAL

prasugrel

Intervention Type: DRUG

taken orally, day one, single dose

Interventions

clopidogrel

taken orally, day one, single dose

Intervention Type: DRUG

prasugrel

taken orally, day one, single dose

Intervention Type: DRUG

Other Intervention Names

Efient®; Effient®; LY640315; CS747

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daiichi Sankyo Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Munich, , Germany

Countries

Germany

References

Bernlochner I, Morath T, Brown PB, Zhou C, Baker BA, Gupta N, Jakubowski JA, Winters KJ, Schomig A, Kastrati A, Sibbing D. A prospective randomized trial comparing the recovery of platelet function after loading dose administration of prasugrel or clopidogrel. Platelets. 2013;24(1):15-25. doi: 10.3109/09537104.2011.654003. Epub 2012 Feb 28.

Reference Type: DERIVED

PMID: 22372531 (View on PubMed)

Other Identifiers

H7T-MC-TACM

Identifier Type: OTHER

Identifier Source: secondary_id

11983

Identifier Type: -

Identifier Source: org_study_id