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

NCT00385944 | Completed Phase 2 Results DMC

• 2 other identifiers: 10632H7T-MC-TABN
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

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

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

  14 days after maintenance dose (MD)

Secondary Outcomes (17)

• MPA to 5 μM ADP

  14 days after maintenance dose (MD)

• Mean Residual Platelet Aggregation (RPA) to 20 µM ADP

  14 days after maintenance dose (MD)

• Mean Residual Platelet Aggregation (RPA) to 5 µM ADP

  14 days after maintenance dose (MD)

• Inhibition Platelet Aggregation (IPA) to 20 μM ADP

  14 days after maintenance dose (MD)

• Inhibition Platelet Aggregation (IPA) to 5 μM ADP

  14 days after maintenance dose (MD)

Study Arms (2)

Prasugrel

EXPERIMENTAL

Open label lead-in one time dose of Clopidogrel 900 mg oral tablets (a single or cumulative dose) and 250 mg to 500 mg aspirin loading dose (LD), either orally or intravenously. Patients are then assigned to maintenance dose (MD) prasugrel 10 mg and two placebo tablets, matched to clopidogrel, and 100 mg aspirin, all taken orally once a day for 14 days. Patients cross-over to MD of clopidogrel two 75 mg tablets and one placebo matched to prasugrel and 100 mg aspirin, all taken orally once a day for the next 14 days.

Drug: Prasugrel

Clopidogrel

ACTIVE COMPARATOR

Open label lead-in one time dose of Clopidogrel 900 mg oral tablets (a single or cumulative dose) and 250 mg to 500 mg aspirin loading dose (LD), either orally or intravenously. Patients are then assigned to maintenance dose (MD) Clopidogrel two 75 mg and one placebo tablet, matched to prasugrel, and 100 mg aspirin, all taken orally once a day for 14 days. Patients cross-over to MD of prasugrel one 10 mg tablet and two placebo tablets matched to clopidogrel and 100 mg aspirin, all taken orally once a day for the next 14 days.

Drug: Clopidogrel

Interventions

Prasugrel DRUG

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

Also known as: LY640315, Effient, Efient

Prasugrel

Clopidogrel DRUG

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

Clopidogrel

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Daiichi Sankyo: collaborator

Study Sites (2)

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, 94010, France

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.

Paris, 75013, France

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Prasugrel Hydrochloride; Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

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

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 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 6, 2006
• First Posted: October 11, 2006
• Study Start: March 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: September 16, 2010
• Results First Posted: September 16, 2010

Record last verified: 2010-08

Locations

FR (2)