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

NCT00407771 | Unknown Phase 4

• 1 other identifier: 2006-alhaddad
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

platelet function assay; Glycoprotein inhibitors; percutaneous coronary intervention; Diabetes Mellitus

Outcome Measures

Primary Outcomes (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 Outcomes (4)

• 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.

Interventions

Tirofiban DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jordan Hospital: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Jordan Hospital

Amman, 11152, Jordan

Location

Related Publications (7)

• 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. doi: 10.1185/030079902125001380.

  PMID: 12661777 BACKGROUND

• 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. doi: 10.1016/s0002-9149(02)02892-8. No abstract available.

  PMID: 12480064 BACKGROUND

• 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. doi: 10.1016/j.jacc.2004.03.042.

  PMID: 15234398 BACKGROUND

• 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. doi: 10.1016/j.thromres.2004.11.011. Epub 2004 Dec 8.

  PMID: 15850609 BACKGROUND

• 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. doi: 10.1016/s0735-1097(02)02014-4.

  PMID: 12204495 BACKGROUND

• 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. doi: 10.1067/mhj.2002.121734.

  PMID: 11923796 BACKGROUND

• 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. doi: 10.1161/01.CIR.0000157138.02645.11. Epub 2005 Feb 28.

  PMID: 15738352 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Diabetes Mellitus

Interventions

Tirofiban

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Tyrosine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Imad A Alhaddad, MD

  Jordan Cardiovascular Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imad A Alhaddad, MD

CONTACT

0096265626197; alhaddad@pol.net

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 1, 2006
• First Posted: December 5, 2006
• Study Start: November 1, 2007
• Study Completion: December 1, 2008
• Last Updated: October 31, 2007

Record last verified: 2007-10

Locations

JO (1)