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Clinical Trials/NCT01107899
NCT01107899TerminatedPhase 1

Recovery of Platelet Function After a Loading Dose of Prasugrel or Clopidogrel in Aspirin-Treated Subjects Presenting With Symptoms of Acute Coronary Syndromes

Eli Lilly and Company1 site in 1 country29 target enrollmentStarted: October 2009Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Terminated
Enrollment
29
Locations
1
Primary Endpoint
Percentage of Participants Returning to Baseline Platelet Function
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 79 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

clopidogrel 600 mg

Active Comparator

Intervention: clopidogrel (Drug)

prasugrel 60 mg

Active Comparator

Intervention: prasugrel (Drug)

prasugrel 30 mg

Experimental

Intervention: prasugrel (Drug)

Outcomes

Primary Outcomes

Percentage of Participants Returning to Baseline Platelet Function

Time Frame: Days 3, 5, 7, 9, and 11

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.

Secondary Outcomes

  • 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)
  • Platelet Function 24 Hours Post Loading Dose(24 hours post-loading dose)
  • Percentage of Poor Pharmacodynamic Responders by Platelet Aggregation at 24 Hours Post-LD(24 hours post-loading dose)
  • Extent of Initial Inhibition of Platelet Aggregation on the Return of Baseline Platelet Function: Light Transmission Aggregometry (LTA)(Up through 11 days)
  • Extent of Initial Inhibition of Platelet Aggregation to the Return of Baseline Platelet Function: Multiplate® ADP Test and ADP Test High Sensitivity (HS)(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 Hours Post-LD) by LTA (5 and 20 μM ADP)(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 Multiplate® ADP Test and ADP Test High Sensitivity (HS)(Up through 11 days)
  • Platelet Function by LTA at 5 and 20 μM ADP(24 hours post-loading dose)
  • Platelet Function by Multiplate® ADP Test and ADP Test HS(24 hours post-loading dose)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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