Skip to main content
OpenTrials
Completed

NCT Number: NCT00385944

The Effect on Blood Cells, Known as Platelets, Using Prasugrel vs Clopidogrel in Patients With the Heart Problem Acute Coronary Syndrome (ACS)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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., Créteil, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prasugrel

Drug

Prasugrel 10-mg tablet taken orally as a daily maintenance dose for a 14-day treatment period.

Other names: LY640315, Effient, Efient

clopidogrel

Drug

Clopidogrel two 75-mg tablets taken orally as a daily maintenance dose for a 14-day treatment period.

Primary outcomes

  1. Maximum Platelet Aggregation (MPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP)

    Time frame: 14 days after maintenance dose (MD)

    Maximum platelet aggregation (MPA) to 20 μM adenosine diphosphate (ADP) was assessed by light transmission aggregometry (LTA).

Secondary outcomes

  1. MPA to 5 μM ADP

    Time frame: 14 days after maintenance dose (MD)

    Maximum platelet aggregation to 5 μM ADP was assessed by LTA.

  2. Mean Residual Platelet Aggregation (RPA) to 20 µM ADP

    Time frame: 14 days after maintenance dose (MD)

    Residual platelet aggregation is the percentage (%) aggregation value as measured by LTA at 6 minutes after the addition of ADP.

  3. Mean Residual Platelet Aggregation (RPA) to 5 µM ADP

    Time frame: 14 days after maintenance dose (MD)

    Residual platelet aggregation is the percentage (%) aggregation value as measured by LTA at 6 minutes after the addition of ADP.

  4. Inhibition Platelet Aggregation (IPA) to 20 μM ADP

    Time frame: 14 days after maintenance dose (MD)

    IPA is calculated as a percent decrease of MPA from baseline using the following formula:

    ([MPA at baseline - MPA at time of postbaseline] / MPA at baseline) x 100%

  5. Inhibition Platelet Aggregation (IPA) to 5 μM ADP

    Time frame: 14 days after maintenance dose (MD)

    IPA is calculated as a percent decrease of MPA from baseline using the following formula:

    ([MPA at baseline - MPA at time of postbaseline] / MPA at baseline) x 100%

  6. Inhibition of Residual Platelet Aggregation (IRPA) to 20 μM ADP

    Time frame: 14 days after maintenance dose (MD)

    IRPA is calculated as a percent decrease of RPA from baseline using the following formula:

    ([RPA at baseline - RPA at time of postbaseline] / RPA at baseline) x 100%

  7. Inhibition of Residual Platelet Aggregation (IRPA) to 5 μM ADP

    Time frame: 14 days after maintenance dose (MD)

    IRPA is calculated as a percent decrease of RPA from baseline using the following formula:

    ([RPA at baseline - RPA at time of postbaseline] / RPA at baseline) x 100%

  8. Platelet Reactivity Index (PRI)

    Time frame: 14 days after maintenance dose (MD)

    Platelet Reactivity Index percentage was assessed by Vasodilator-stimulated phosphoprotein (VASP). PRI percent (%) was calculated using the median fluorescence intensity (MFI) of samples included with prostaglandin E1 (PGE1) and ADP, according to the following formula:

    PRI%=[(MFI(PGE1)-MFI(PGE1 + ADP)/MFI(PGE1)]x100

    Lower PRI% values indicate greater P2Y12 receptor blockade.

  9. P2Y12 Reaction Units (PRU)

    Time frame: 14 days after maintenance dose (MD)

    P2Y12 Reaction Units (PRU) assessed by Accumetrics Verify NowTM P2Y12. PRU represents the rate and extent of adenosine (ADP)-stimulated platelet aggregation. Lower values indicate greater P2Y12 platelet inhibition.

  10. Poor Responder of MPA to 20 μM ADP Following Maintenance Dose (MD)

    Time frame: 14 days after maintenance dose (MD)

    Poor responder is defined as MPA to 20 μM ADP >75th percentile of the value at 6-18 hours post-clopidogrel LD.

  11. Change in MPA to 20 μM ADP From Baseline to 6-18 Hrs Post Loading Dose (LD)

    Time frame: Baseline to 6-18 hrs post loading dose (LD)

    Maximum platelet aggregation to 20 μM ADP was assessed by LTA.

  12. Change in MPA to 20 μM ADP From 6-18 Hrs Post Loading Dose (LD) to 14 Days After the First Maintenance Dose (MD)

    Time frame: 6-18 hrs post loading dose (LD) to 14 days after the first maintenance dose (MD)

    Maximum platelet aggregation to 20 μM ADP was assessed by LTA.

  13. MPA to 20 μM ADP at 14 Days After the First Maintenance Dose (MD)

    Time frame: 14 days after the first maintenance dose (MD)

    Maximum platelet aggregation to 20 μM ADP was assessed by LTA.

  14. MPA to 20 μM ADP at 14 Days After the Second Maintenance Dose (MD)

    Time frame: 14 days after the second maintenance dose (MD)

    Maximum platelet aggregation to 20 μM ADP was assessed by LTA.

  15. Number of Participants With Bleeding Events According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria

    Time frame: 14 days after maintenance dose (MD)

    Bleeding events will be classified as Major Bleeding, Minor Bleeding, or Insignificant Bleeding according to the TIMI criteria. Major bleeding: any intracranial hemorrhage (ICH) OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 gm/dL from baseline. Minor Bleeding: any clinically overt bleeding associated with a fall in Hgb of ≥3 grams/deciliter (gm/dL) but <5 gm/dL from baseline. Insignificant bleeding: any bleeding event that does not meet criteria for a Major or Minor bleed.

  16. Number of Participants With Bleeding Events According to Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO)

    Time frame: 14 days after maintenance dose (MD)

    Bleeding events will be classified according to the GUSTO definitions as follows: Severe or Life-Threatening Bleeding: any ICH OR any bleeding event resulting in substantial hemodynamic compromise requiring treatment. Moderate Bleeding: any bleeding event resulting in the need for transfusion. Minor bleeding: any other bleeding event that does not require transfusion or cause hemodynamic compromise.

  17. Correlation of MPA to 20 μM ADP and PRU

    Time frame: Baseline through 29 days of treatment

    Pearson-correlation estimated between MPA to 20 μM ADP and Accumetrics VerifyNowTM P2Y12 PRU

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Daiichi Sankyo

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Oct 11, 2006
Registry last updated
Sep 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.