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The Effects of Tirofiban in Diabetic Patients Undergoing Elective Percutaneous Coronary Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00407771
Recruitment Status : Unknown
Verified October 2007 by Jordan Hospital.
Recruitment status was:  Not yet recruiting
First Posted : December 5, 2006
Last Update Posted : October 31, 2007
Merck Sharp & Dohme Corp.
Information provided by:
Jordan Hospital

Brief Summary:
  • The purpose of this study is to examine the effects of tirofiban on platelet function the Ultegra RPFA in diabetic patients undergoing elective coronary angioplasty and stenting already treated with high loading dose (600mg) clopidogrel.
  • About 44 people will be in the study. The study duration is a single hospitalization period during which the angioplasty will be performed in addition to a 30-day post hospitalization follow-up period.
  • Patients taking part in the study will be assigned by chance into two groups.

    • Group 1: patients will be treated with the glycoprotein inhibitor, Tirofiban (25mcg/kg over 3 min bolus dose and 0.15 mcg/kg/hr for 12-24 hours), started immediately after insertion of the sheath.
    • Group 2: patients will be treated with equivalent placebo

All patients will be loaded with 600 mg clopidogrel at least 4 hours prior to scheduled intervention.

All patients will have platelet function analyses at baseline and following treatment.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Tirofiban Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of The Effects of a Single High Dose Bolus Tirofiban in Diabetic Patients Undergoing Elective Percutaneous Coronary Intervention
Study Start Date : November 2007
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Tirofiban

Primary Outcome Measures :
  1. The magnitude of platelet aggregation inhibition before randomization, 10 minutes (t=0) and 8 hours (t=8) post tirofiban administration using the Ultegra RPFA assay.

Secondary Outcome Measures :
  1. The difference of flow cytometry and platelet monocyte aggregation between the two groups.
  2. The incidence of troponin T release 12 hours post PCI among the two groups.
  3. The difference in mean troponin T between the groups at 12 hours post PCI.
  4. Major adverse cardiac events (MACE) at 24 hours and 30 days post PCI.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diabetic patients with coronary artery disease undergoing elective percutaneous coronary intervention

Exclusion Criteria:

  • Ongoing ST-segment elevation myocardial infarction (MI)
  • Administration of abciximab during the previous two weeks
  • Serum creatinine more than 2.5 mg/dl (221 micro-mol/L)
  • Ongoing bleeding or bleeding diathesis
  • Previous stroke in the last six months
  • Major surgery within the previous six weeks
  • Platelet count <100.000 per cubic mm
  • Subjects who received low-molecular-weight heparin, tirofiban, or eptifibatide within the 10 hours prior to randomization
  • Subjects on oral anticoagulation medication (coumarin derivatives) within the last 7 days unless PT-INR <1.5 times the control

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00407771

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Contact: Imad A Alhaddad, MD 0096265626197

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Jordan Hospital
Amman, Jordan, 11152
Principal Investigator: Imad A Alhaddad, MD         
Sponsors and Collaborators
Jordan Hospital
Merck Sharp & Dohme Corp.
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Principal Investigator: Imad A Alhaddad, MD Jordan Cardiovascular Center

Layout table for additonal information Identifier: NCT00407771    
Other Study ID Numbers: 2006-alhaddad
First Posted: December 5, 2006    Key Record Dates
Last Update Posted: October 31, 2007
Last Verified: October 2007
Keywords provided by Jordan Hospital:
platelet function assay
Glycoprotein inhibitors
percutaneous coronary intervention
Diabetes Mellitus
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors