Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00097591
Other study ID # 8695
Secondary ID H7T-MC-TAAL
Status Completed
Phase Phase 3
First received November 24, 2004
Last updated August 25, 2010
Start date November 2004
Est. completion date July 2007

Study information

Verified date August 2010
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The sponsors of this investigational drug are developing prasugrel (also known as CS-747) as a possible treatment for patients with acute coronary syndrome (heart attack or chest pain) who need, or are expected to need, a percutaneous coronary intervention (PCI; also called a balloon angioplasty). Prasugrel was compared with Clopidogrel to determine which drug is better at reducing deaths, future heart attacks, or stroke.


Recruitment information / eligibility

Status Completed
Enrollment 13619
Est. completion date July 2007
Est. primary completion date July 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- A person who has been diagnosed with acute coronary syndrome and is to undergo a percutaneous coronary intervention.

- A person who is of the legal age of 18 and is mentally competent to provide a signed written informed consent.

- If a woman is of childbearing potential (i.e., before menopause), she must test negative for pregnancy and agree to use a reliable method of birth control.

Exclusion Criteria:

- A person who has had an ischemic stroke within the last 3 months or a hemorrhagic stroke at any time in the past.

- A person who has active internal bleeding or has a history of a bleeding disorder.

- Individuals who are at an increased risk of bleeding based on laboratory criteria evaluated by the treatment physician or on medication that can cause bleeding.

- A person who has liver disease; for example, cirrhosis.

- A person who has a condition such as alcoholism, mental illness, or is drug dependent.

- A person who has cardiogenic shock, a refractory ventricular arrhythmia, or congestive heart failure (class IV).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
Prasugrel
Administered orally
Clopidogrel
Administered orally

Locations

Country Name City State
United States For more information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), Global Quintiles Study Line (1-866-615-4672) or speak with your physician Indianapolis Indiana

Sponsors (2)

Lead Sponsor Collaborator
Eli Lilly and Company Daiichi Sankyo Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Pride YB, Tung P, Mohanavelu S, Zorkun C, Wiviott SD, Antman EM, Giugliano R, Braunwald E, Gibson CM; TIMI Study Group. Angiographic and clinical outcomes among patients with acute coronary syndromes presenting with isolated anterior ST-segment depression — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke The endpoint in this measure is a combination of CV death, nonfatal MI, or nonfatal stroke. The data is presented by the study population, which is represented as follows: 1) subjects who presented with unstable angina and non-ST-segment elevation myocardial infarction (UA/NSTEMI), 2) subjects who presented with ST segment elevation myocardial infarction (STEMI), and 3) all subjects with acute coronary syndromes (ACS) (i.e. all subjects with UA/NSTEMI or STEMI). Randomization up to 15 months No
Secondary Number of Treated Subjects With Non-Coronary Artery Bypass Graft (CABG) Related Thrombolysis In Myocardial Infarction (TIMI) Study Group Major and Minor Bleeding Events TIMI classification for major and minor bleeding in the subset of subjects who did not undergo a coronary artery bypass operation (CABG) were defined as follows: 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 grams/deciliter (gm/dL)from baseline. Minor Bleeding: any clinically overt bleeding associated with a fall in Hgb of =3 gm/dL but <5 gm/dL from baseline. Major bleeding events were further examined as events that were deemed life threatening and/or fatal. First dose of study drug up to 15 months (while at risk) Yes
Secondary Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Urgent Target Vessel Revascularization (UTVR) The endpoint in this measure is a combination of CV death, nonfatal MI, or UTVR. Results are reported for the All ACS subject population for the 30 and 90 day periods. Randomization to 30 days; randomization to 90 days No
Secondary Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke The endpoint in this measure is a combination of CV death, nonfatal MI, or nonfatal stroke. Results are reported for the All ACS population for the 30 and 90 day periods. Randomization to 30 days; randomization to 90 days No
Secondary Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Rehospitalization for Cardiac Ischemic Events The endpoint in this measure is a combination of CV death, nonfatal MI, nonfatal stroke, or rehospitalization for cardiac ischemic events. Results are reported for the All ACS population. Randomization up to 15 months No
Secondary Number of Subjects Reaching the Composite Endpoint of All-Cause Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke The endpoint in this measure is a combination of all-cause death, nonfatal MI, or nonfatal stroke. Results are reported for the All ACS population. Randomization up to 15 months No
See also
  Status Clinical Trial Phase
Completed NCT00069654 - Dietary Nitrate and Nitrite to Increase Nitric Oxide in Patients With Coronary Artery Disease Phase 2
Completed NCT02919124 - Epicardial Echocardiography of Coronary Anastomoses Using the Echoclip Device N/A
Recruiting NCT02639962 - Characteristics of Culprit Lesion and Changes in Plaque Composition. A Dual Energy Cardiac CT Study N/A
Completed NCT02494557 - Risk Stratification for Coronary Artery Disease With Type 2 Diabetic Patients N/A
Recruiting NCT01466452 - Antiplatelet Effect of Low Doses of Aspirin Taken Every 12 Hours in Patients Undergoing Coronary Artery Bypass Graft and/or Aortic Valve Surgery Phase 2
Completed NCT01182428 - XIENCE V: SPIRIT WOMEN Sub-study Phase 4
Completed NCT00371891 - Ontario Multidetector Computed Tomographic (MDCT) Coronary Angiography Study (OMCAS) Phase 4
Completed NCT00368953 - YUKON Choice Versus TAXUS Liberté in Diabetes Mellitus Phase 4
Completed NCT00319449 - Adding Ezetimibe Tablet to Ongoing Treatment With Atorvastatin in Subjects With High Cholesterol and Multiple Coronary Heart Disease Risk Factors (Study P04060)(COMPLETED) Phase 4
Completed NCT00091754 - Atherosclerosis, Plaque and CVD in Communities
Completed NCT00069797 - Epidemiology of Coronary Heart Disease in Men Aged 40 and Over N/A
Completed NCT00024596 - Family Heart Study - Subclinical Atherosclerosis Network (FHS-SCAN) N/A
Completed NCT00037245 - Androgens and Subclinical Atherosclerosis in Young Women - Ancillary to CARDIA N/A
Completed NCT00006502 - Myocardial Perfusion, Risk Factors, and Coronary Calcium N/A
Withdrawn NCT00006497 - Long-Term Effects of Subclinical CAD on Cardiac Function
Completed NCT00006407 - Sex Steroid Hormones and Risk of CHD in Women N/A
Completed NCT00006309 - Pooling of Cohort Studies on Diet & Coronary Disease N/A
Completed NCT00005269 - Family Blood Pressure Program - GENOA
Completed NCT00000508 - Stanford Coronary Risk Intervention Project (SCRIP) Phase 3
Completed NCT00005147 - Epidemiology of Atherosclerosis N/A

External Links