The Effects of Tirofiban in Diabetic Patients Undergoing Elective Percutaneous Coronary Intervention - Full Text View

Sponsors and Collaborators:	Jordan Hospital Merck
Information provided by:	Jordan Hospital
ClinicalTrials.gov Identifier:	NCT00407771

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 IV

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Krestin Tirofiban Tirofiban hydrochloride Tirofiban hydrochloride monohydrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Pilot Study of The Effects of a Single High Dose Bolus Tirofiban in Diabetic Patients Undergoing Elective Percutaneous Coronary Intervention

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
Amman, Jordan, 11152

Sponsors and Collaborators

Jordan Hospital

Merck

Investigators

Principal Investigator:

Imad A Alhaddad, MD

Jordan Cardiovascular Center

More Information

Publications:

Danzi GB, Capuano C, Sesana M, Baglini R. Preliminary experience with a high bolus dose of tirofiban during percutaneous coronary intervention. Curr Med Res Opin. 2003;19(1):28-33.

Schneider DJ, Herrmann HC, Lakkis N, Aguirre F, Wan Y, Aggarwal A, Kabbani SS, DiBattiste PM. Enhanced early inhibition of platelet aggregation with an increased bolus of tirofiban. Am J Cardiol. 2002 Dec 15;90(12):1421-3. No abstract available.

Valgimigli M, Percoco G, Barbieri D, Ferrari F, Guardigli G, Parrinello G, Soukhomovskaia O, Ferrari R. The additive value of tirofiban administered with the high-dose bolus in the prevention of ischemic complications during high-risk coronary angioplasty: the ADVANCE Trial. J Am Coll Cardiol. 2004 Jul 7;44(1):14-9.

Kimmelstiel C, Badar J, Covic L, Waxman S, Weintraub A, Jacques S, Kuliopulos A. Pharmacodynamics and pharmacokinetics of the platelet GPIIb/IIIa inhibitor tirofiban in patients undergoing percutaneous coronary intervention: implications for adjustment of tirofiban and clopidogrel dosage. Thromb Res. 2005;116(1):55-66. Epub 2004 Dec 8.

Bonz AW, Lengenfelder B, Strotmann J, Held S, Turschner O, Harre K, Wacker C, Waller C, Kochsiek N, Meesmann M, Neyses L, Schanzenbacher P, Ertl G, Voelker W. Effect of additional temporary glycoprotein IIb/IIIa receptor inhibition on troponin release in elective percutaneous coronary interventions after pretreatment with aspirin and clopidogrel (TOPSTAR trial). J Am Coll Cardiol. 2002 Aug 21;40(4):662-8.

Wheeler GL, Braden GA, Steinhubl SR, Kereiakes DJ, Kottke-Marchant K, Michelson AD, Furman MI, Mueller MN, Moliterno DJ, Sane DC. The Ultegra rapid platelet-function assay: comparison to standard platelet function assays in patients undergoing percutaneous coronary intervention with abciximab therapy. Am Heart J. 2002 Apr;143(4):602-11.

Gurbel PA, Bliden KP, Zaman KA, Yoho JA, Hayes KM, Tantry US. Clopidogrel loading with eptifibatide to arrest the reactivity of platelets: results of the Clopidogrel Loading With Eptifibatide to Arrest the Reactivity of Platelets (CLEAR PLATELETS) study. Circulation. 2005 Mar 8;111(9):1153-9. Epub 2005 Feb 28.

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

Keywords provided by Jordan Hospital:

platelet function assay
Glycoprotein inhibitors
percutaneous coronary intervention
Diabetes Mellitus

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Tirofiban
Myocardial Ischemia
Vascular Diseases

Diabetes Mellitus
Arteriosclerosis
Ischemia
PS-K
Coronary Artery Disease

Additional relevant MeSH terms:

Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors

Fibrinolytic Agents
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009