Clinical trial NCT00385944: The Effect on Blood Cells, Known as Platelets, Using Prasugrel vs Clopidogrel in Patients With the Heart Problem Acute Coronary Syndrome (ACS)
Official title: A Randomized Double-Blind Cross-Over Study Comparing the Pharmacodynamic (PD)Response in Subjects With ACS Receiving 14 Days 10-mg Maintenance Dose (MD) Prasugrel vs 14 Days 150-mg MD Clopidogrel After Using a 900-mg Loading Dose (LD) of Clopidogrel to Reduce Ongoing Platelet Activation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Coronary Syndrome
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Daiichi Sankyo
First posted: 2006-10-11
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a multicenter, randomized, double-blind, cross-over study to compare the pharmacodynamic response in subjects with Acute Coronary Syndrome receiving a 10-mg maintenance dose (MD) of prasugrel compared with a 150-mg maintenance dose of clopidogrel, following a 900-mg loading dose (LD) of clopidogrel.


Eligibility criteria: Inclusion Criteria:

* Present with acute coronary syndrome (ACS) and have planned treatment with a one-time 900-mg loading dose of commercially available clopidogrel (administered as a single or cumulative dose).
* Are between the ages of 18 and 85 years.
* Willing and able to sign informed consent.

Exclusion Criteria:

* Have overt ST-segment elevation myocardial infarction (STEMI).
* Have cardiogenic shock.
* Have refractory ventricular arrhythmias.
* Have New York Heart Association (NYHA) Class IV congestive heart failure.
* Have severe and uncontrolled hypertension.
* Have active internal bleeding or history of bleeding diathesis.
* Have an increased risk of bleeding.
* Have history of cerebrovascular accidents.
* Have certain abnormal blood level values.
* Are currently receiving chemotherapy or radiation therapy.

Primary outcomes:
measure: Maximum Platelet Aggregation (MPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP)
timeFrame: 14 days after maintenance dose (MD)
Secondary outcomes:
measure: MPA to 5 μM ADP
timeFrame: 14 days after maintenance dose (MD)
measure: Mean Residual Platelet Aggregation (RPA) to 20 µM ADP
timeFrame: 14 days after maintenance dose (MD)
measure: Mean Residual Platelet Aggregation (RPA) to 5 µM ADP
timeFrame: 14 days after maintenance dose (MD)
measure: Inhibition Platelet Aggregation (IPA) to 20 μM ADP
timeFrame: 14 days after maintenance dose (MD)
measure: Inhibition Platelet Aggregation (IPA) to 5 μM ADP
timeFrame: 14 days after maintenance dose (MD)
measure: Inhibition of Residual Platelet Aggregation (IRPA) to 20 μM ADP
timeFrame: 14 days after maintenance dose (MD)
measure: Inhibition of Residual Platelet Aggregation (IRPA) to 5 μM ADP
timeFrame: 14 days after maintenance dose (MD)
measure: Platelet Reactivity Index (PRI)
timeFrame: 14 days after maintenance dose (MD)
measure: P2Y12 Reaction Units (PRU)
timeFrame: 14 days after maintenance dose (MD)
measure: Poor Responder of MPA to 20 μM ADP Following Maintenance Dose (MD)
timeFrame: 14 days after maintenance dose (MD)
measure: Change in MPA to 20 μM ADP From Baseline to 6-18 Hrs Post Loading Dose (LD)
timeFrame: Baseline to 6-18 hrs post loading dose (LD)
measure: Change in MPA to 20 μM ADP From 6-18 Hrs Post Loading Dose (LD) to 14 Days After the First Maintenance Dose (MD)
timeFrame: 6-18 hrs post loading dose (LD) to 14 days after the first maintenance dose (MD)
measure: MPA to 20 μM ADP at 14 Days After the First Maintenance Dose (MD)
timeFrame: 14 days after the first maintenance dose (MD)
measure: MPA to 20 μM ADP at 14 Days After the Second Maintenance Dose (MD)
timeFrame: 14 days after the second maintenance dose (MD)
measure: Number of Participants With Bleeding Events According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria
timeFrame: 14 days after maintenance dose (MD)
measure: Number of Participants With Bleeding Events According to Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO)
timeFrame: 14 days after maintenance dose (MD)
measure: Correlation of MPA to 20 μM ADP and PRU
timeFrame: Baseline through 29 days of treatment
Other outcomes:
Locations:
city: Creteil
country: France
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.
city: Paris
country: France
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: