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

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ClinicalTrials.gov Identifier: NCT00132912
Recruitment Status : Completed
First Posted : August 22, 2005
Last Update Posted : May 25, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:

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 or disease Intervention/treatment Phase
Arterial Obstructive Diseases Coronary Disease Drug: SCH 530348 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1030 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Actual Study Start Date : August 30, 2005
Actual Primary Completion Date : January 28, 2007
Actual Study Completion Date : January 28, 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Additional Information:
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00132912     History of Changes
Other Study ID Numbers: P03573
First Posted: August 22, 2005    Key Record Dates
Last Update Posted: May 25, 2017
Last Verified: May 2017

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

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Arterial Occlusive Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Vorapaxar
Platelet Aggregation Inhibitors