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

NCT01107899 | Terminated Phase 1 Results

• 2 other identifiers: 11983H7T-MC-TACM
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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

Keywords

Acute Coronary Syndromes; Angina; Platelet Function; Coronary Angiography; Clinical Symptoms of Angina; Positive Stress Test

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Returning to Baseline Platelet Function

  Participants were classified as having platelet function return to baseline after loading dose (LD) on the first day that P2Y12 Reaction Units (PRU) was no more than 60 PRU below baseline and remained in this range. PRU was assessed by Accumetrics Verify Now™ P2Y12. PRU represents the rate and extent of adenosine diphosphate (ADP)-stimulated platelet aggregation.

  Days 3, 5, 7, 9, and 11

Secondary Outcomes (13)

• The Day on Which 50%, 75% and 90% of Subjects Return to Baseline Platelet Function Following a Single LD of 30-mg or 60-mg Prasugrel or 600-mg Clopidogrel

  Up through 11 days

• The Day When the Proportion of Participants Who Return to Baseline Platelet Function in the 30-mg and 60-mg Prasugrel Groups is Similar to the 600-mg Clopidogrel Group at Day 5 and Day 7

  Up through 11 days

• Number of Days to the Return of Baseline Platelet Function Following One Loading Dose (LD)

  Up through 11 days

• Effect of Initial Inhibition of Platelet Aggregation on the Day to Return to Baseline Platelet Function: VN-PRU

  Up through 11 days

• Mean Number of Days to the Return of Baseline Platelet Function in All Treatment Arms (Adjusted for Level of Inhibition 24 Hrs Post-LD) by VN-PRU

  Up through 11 days

Study Arms (3)

clopidogrel 600 mg

ACTIVE COMPARATOR

Drug: clopidogrel

prasugrel 60 mg

ACTIVE COMPARATOR

Drug: prasugrel

prasugrel 30 mg

EXPERIMENTAL

Drug: prasugrel

Interventions

clopidogrel DRUG

taken orally, day one, single dose

clopidogrel 600 mg

prasugrel DRUG

taken orally, day one, single dose

Also known as: Efient®, Effient®, LY640315, CS747

prasugrel 30 mg; prasugrel 60 mg

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Daiichi Sankyo Co., Ltd.: collaborator

Study Sites (1)

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, 80636, Germany

Location

Related Publications (1)

• 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.

  PMID: 22372531 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Angina Pectoris

Interventions

Clopidogrel; Prasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Piperazines

Limitations and Caveats

Trial was terminated early due to enrollment futility which resulted in limited data and the inability to analyze some outcome measures.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2010
• First Posted: April 21, 2010
• Study Start: October 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 9, 2012
• Results First Posted: January 12, 2012

Record last verified: 2012-03

Locations

DE (1)