NCT00642174

Brief Summary

This trial is designed as a phase 2 randomized, double-blind double dummy, active comparator controlled, two-period two-arm crossover study to enroll 40 patients across multiple centers. The study will compare platelet function following a prasugrel loading dose and 1 week of prasugrel maintenance therapy with high-dose clopidogrel loading dose and 1 week of high-dose clopidogrel maintenance therapy in patients with drug treated type 2 diabetes mellitus who have coronary artery disease. Various assays of platelet function will be used in this study. Platelet function will be studied using the following assays: Accumetrics VerifyNowTM P2Y12, Light Transmittance Aggregometry (LTA), Vasodilator-associated stimulated phosphoprotein (VASP), and Thromboelastography (TEG)-platelet mapping.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at below P25 for phase_2 diabetes-mellitus

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_2 diabetes-mellitus

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 24, 2008

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 12, 2010

Completed
Last Updated

February 23, 2010

Status Verified

February 1, 2010

Enrollment Period

9 months

First QC Date

March 21, 2008

Results QC Date

January 18, 2010

Last Update Submit

February 19, 2010

Conditions

Diabetes MellitusCoronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Inhibition of Platelet Aggregation (IPA) 4 Hours After Loading Dose Assessed by Accumetrics VerifyNowâ„¢ P2Y12 Assay

    The inhibition of platelet aggregation 4 hours after the loading dose was administered was assessed using the Accumetrics VerifyNowâ„¢ P2Y12 assay. Percentage inhibition, as reported by VerifyNowâ„¢ P2Y12, was calculated from P2Y12 Reaction Unit (PRU) (rate and extent of adenosine diphosphate \[ADP\]-stimulated platelet aggregation) and BASE (estimate of baseline platelet reactivity independent of P2Y12 receptor inhibition \[reference values\]: rate and extent of Thrombin Receptor-Activated Peptide-stimulated platelet aggregation) values as follows: Percentage (%) inhibition = (1-PRU/BASE) x 100.

    4 hours after loading dose

Secondary Outcomes (4)

  • Inhibition of Platelet Aggregation at 1- and 24-Hours After Loading Dose (LD) and 24-Hours After Last Maintenance Dose (LMD) Assessed by Accumetrics VerifyNowâ„¢ P2Y12 Assay

    1 hour and 24 hours after the loading dose (LD) and 24 hours after the last maintenance dose (LMD)

  • Maximum Platelet Aggregation (MPA) as Assessed by Light Transmittance Aggregometry (LTA)

    Baseline, 1 Hour, 4 Hours, and 24 Hours after loading dose, and 24 Hours after last maintenance dose

  • Platelet Reactivity Index (PRI)

    Baseline, 1 Hour, 4 Hours, and 24 Hours after loading dose, and 24 Hours after last maintenance dose

  • Inhibition of Platelet Function as Measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate

    Baseline, 1 Hour, 4 Hours, and 24 Hours after loading dose, and 24 Hours after last maintenance dose

Study Arms (2)

Prasugrel

EXPERIMENTAL

Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.

Drug: prasugrel

Clopidogrel

ACTIVE COMPARATOR

Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.

Drug: Clopidogrel

Interventions

prasugrelDRUG

Oral prasugrel 60-mg loading dose, followed by 6-9 days of oral prasugrel 10-mg/day tablet maintenance dose.

Also known as: LY640315, Effient, Efient
Prasugrel
ClopidogrelDRUG

Oral clopidogrel 600-mg loading dose, followed by 6-9 days of oral clopidogrel 150-mg/day tablet maintenance dose.

Clopidogrel

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 Diabetes Mellitus and on oral or parenteral hypoglycemic therapy for at least 1 month.
  • History of Coronary Artery Disease with or without other types of vascular disease (such as peripheral vascular disease).
  • Taking Aspirin 75-325 mg/day for at least 1 week prior to randomization.
  • Between the ages of 18-74 years old.
  • If a woman of child bearing age, must not be pregnant and must agree to use reliable method of birth control during the duration of the study.

You may not qualify if:

  • Thienopyridine therapy within 30 days or have a defined need for thienopyridine treatment.
  • Coronary Artery Bypass Graft (CABG) or Percutaneous Coronary Intervention (PCI) with no stent placed within 30 days.
  • Planned coronary revascularization
  • Hemoglobin A1c (HbA1c) \> or equal to 10 mg/dL within the last 3 months.
  • Received fibrolytic therapy \<24 hours prior to randomization.
  • Received non-fibrin-specific fibrinolytic therapy \<48 hours prior to randomization.
  • At risk of bleeding.
  • History of ischemic stroke, transient ischemic attack (TIA), intercranial neoplasm, arteriovenous malformation, or aneurysm.
  • Body weight \<60 kilograms (kg).
  • International Normalized Ratio (INR) \>1.5, platelet count \<100,000/mm3, or anemia (hemoglobin \<10 gm/dL) within 1 week of study entry.
  • Are receiving or will receive oral anticoagulation or antiplatelet treatment therapy.
  • Are being treated with daily non-steroidal anti-inflammatory drugs (NSAIDS).
  • Are pregnant, breast-feeding or plan to become pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

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.

Jacksonville, Florida, 32209, United States

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.

Worcester, Massachusetts, 01655, United States

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.

New York, New York, 10029, United States

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.

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (1)

  • Angiolillo DJ, Badimon JJ, Saucedo JF, Frelinger AL, Michelson AD, Jakubowski JA, Zhu B, Ojeh CK, Baker BA, Effron MB. A pharmacodynamic comparison of prasugrel vs. high-dose clopidogrel in patients with type 2 diabetes mellitus and coronary artery disease: results of the Optimizing anti-Platelet Therapy In diabetes MellitUS (OPTIMUS)-3 Trial. Eur Heart J. 2011 Apr;32(7):838-46. doi: 10.1093/eurheartj/ehq494. Epub 2011 Jan 20.

    PMID: 21252171DERIVED

Related Links

MeSH Terms

Conditions

Diabetes MellitusCoronary Artery Disease

Interventions

Prasugrel HydrochlorideClopidogrel

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTiclopidineThienopyridinesPyridinesHeterocyclic Compounds, 2-RingHeterocyclic 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 9am-5pm 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

March 21, 2008

First Posted

March 24, 2008

Study Start

April 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

February 23, 2010

Results First Posted

February 12, 2010

Record last verified: 2010-02

Locations

US(4)