Safety of SCH 530348 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention (Study P03573)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: August 19, 2005
Last updated: May 24, 2016
Last verified: May 2016

The object of the study is to determine whether different doses of SCH 530348, when added to standard medical care in persons undergoing percutaneous coronary intervention, will increase the risk of bleeding.

A secondary objective is to determine whether patients treated with SCH 530348 have fewer cardiac events such as heart attack, bypass surgery, or death compared with those persons treated with the standard of care.

Condition Intervention Phase
Arterial Obstructive Diseases
Coronary Disease
Drug: SCH 530348
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of SCH 530348 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Incidence of bleeding through the end of treatment in subjects undergoing percutaneous coronary intervention

Secondary Outcome Measures:
  • Incidence of bleeding throughout treatment and follow-up
  • Incidence of death and major adverse cardiac events

Enrollment: 1030
Study Start Date: August 2005
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • A person who is 45 years or older and is mentally competent to provide a signed written informed consent.
  • A person who is scheduled to undergo a percutaneous coronary intervention or a heart catheterization with the intent to undergo a percutaneous coronary intervention.
  • If a woman is of childbearing potential (ie, before menopause), she must test negative for pregnancy and agree to use a reliable method of birth control.

Exclusion Criteria:

  • Pregnancy
  • Recent stroke
  • Active internal bleeding or a history of a bleeding disorder
  • Increased risk of bleeding
  • Severe high blood pressure
  • Liver or kidney disease
  • Low platelet count
  • Condition such as alcoholism, mental illness, or drug dependence
  • Ongoing chest pain
  • Planned or ongoing treatment with a blood thinning medication
  • A serious condition or illness that would interfere with participation in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00132912     History of Changes
Other Study ID Numbers: P03573 
Study First Received: August 19, 2005
Last Updated: May 24, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Platelet Aggregation Inhibitors
Protease-Activated Receptor 1

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Coronary Artery Disease
Coronary Disease
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Platelet Aggregation Inhibitors
Vorapaxar processed this record on May 26, 2016