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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Jordan Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Merck
Information provided by:
Jordan Hospital
ClinicalTrials.gov Identifier:
NCT00407771
First received: December 1, 2006
Last updated: October 30, 2007
Last verified: October 2007
History of Changes
  Purpose
  • 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 Intervention Phase
Coronary Artery Disease
 Drug: Tirofiban
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Jordan Hospital:

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

Estimated Enrollment: 44
Study Start Date: November 2007
Estimated Study Completion Date: December 2008
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00407771

Contacts
Contact: Imad A Alhaddad, MD 0096265626197 alhaddad@pol.net

Locations
Jordan
Jordan Hospital Not yet recruiting
Amman, Jordan, 11152
Principal Investigator: Imad A Alhaddad, MD            
Sponsors and Collaborators
Jordan Hospital
Merck
Investigators
Principal Investigator: Imad A Alhaddad, MD Jordan Cardiovascular Center
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00407771     History of Changes
Other Study ID Numbers: 2006-alhaddad
Study First Received: December 1, 2006
Last Updated: October 30, 2007
Health Authority: Jordan: Ministry of health

Keywords provided by Jordan Hospital:
platelet function assay
Glycoprotein inhibitors
percutaneous coronary intervention
Diabetes Mellitus

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Tirofiban
 Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013