Clinical trial NCT01107899: Study to Learn When Platelets Return to Normal After One Loading Dose of Anti-platelet Drugs in Patients With Symptoms of Acute Coronary Syndromes
Official title: Recovery of Platelet Function After a Loading Dose of Prasugrel or Clopidogrel in Aspirin-Treated Subjects Presenting With Symptoms of Acute Coronary Syndromes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Acute Coronary Syndromes
Keywords: Acute Coronary Syndromes
Angina
Platelet Function
Coronary Angiography
Clinical Symptoms of Angina
Positive Stress Test
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Daiichi Sankyo Co., Ltd.
First posted: 2010-04-21
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Participants Returning to Baseline Platelet Function
timeFrame: Days 3, 5, 7, 9, and 11
Secondary outcomes:
measure: 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
timeFrame: Up through 11 days
measure: 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
timeFrame: Up through 11 days
measure: Number of Days to the Return of Baseline Platelet Function Following One Loading Dose (LD)
timeFrame: Up through 11 days
measure: Effect of Initial Inhibition of Platelet Aggregation on the Day to Return to Baseline Platelet Function: VN-PRU
timeFrame: Up through 11 days
measure: 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
timeFrame: Up through 11 days
measure: Platelet Function 24 Hours Post Loading Dose
timeFrame: 24 hours post-loading dose
measure: Percentage of Poor Pharmacodynamic Responders by Platelet Aggregation at 24 Hours Post-LD
timeFrame: 24 hours post-loading dose
measure: Extent of Initial Inhibition of Platelet Aggregation on the Return of Baseline Platelet Function: Light Transmission Aggregometry (LTA)
timeFrame: Up through 11 days
measure: Extent of Initial Inhibition of Platelet Aggregation to the Return of Baseline Platelet Function: Multiplate® ADP Test and ADP Test High Sensitivity (HS)
timeFrame: Up through 11 days
measure: 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)
timeFrame: Up through 11 days
measure: 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)
timeFrame: Up through 11 days
measure: Platelet Function by LTA at 5 and 20 μM ADP
timeFrame: 24 hours post-loading dose
measure: Platelet Function by Multiplate® ADP Test and ADP Test HS
timeFrame: 24 hours post-loading dose
Other outcomes:
Locations:
city: Munich
country: Germany
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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
References:
citation: 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.