Study of Tirofiban Administration in Patients With Aspirin and or Clopidogrel Resistance

NCT00398463 | Completed Phase 4 DMC

• 1 other identifier: TCA-01-III
• Study Type: interventional
• Target: 263
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate whether adding tirofiban, administered at high bolus dose on top of aspirin and clopidogrel will lead to a lower rate of periprocedural myocardial infarction after percutaneous coronary intervention in elective patients presenting with aspirin and/or clopidogrel resistance.

Conditions

Angioplasty, Transluminal, Percutaneous Coronary

Keywords

tirofiban; aspirin resistance; clopidogrel resistance

Outcome Measures

Primary Outcomes (1)

• Troponin I or T elevation ratio at least three times the upper limit of normal.

  48 hours

Secondary Outcomes (5)

• The incidence of myocardial infarction defined as elevation of CK-MB >1, ≥3 or ≥5 times the ULN in one or more blood sample(s).

  30 days

• Elevation of troponin levels above upper limit of normal in ratios different from the primary endpoint

  within 30 days

• Bleeding rates

  30 days

• Stent thrombosis

  with the first year of follow-up

• The rate of major adverse cardiovascular events

  at 30 days and 1 year

Study Arms (2)

1

EXPERIMENTAL

Aspirin, clopidogrel, Unfractioned heparin or bivalirudin plus tirofiban infusion given at high bolus dose

Drug: Tirofiban

2

PLACEBO COMPARATOR

Aspirin, clopidogrel, Unfractioned heparin or bivalirudin plus placebo

Drug: Placebo

Interventions

Tirofiban DRUG

Tirofiban infusion given as high bolus dose plus standard 14-24 hour infusion

Also known as: Glycoprotein IIb/IIIa inhibitor

1

Placebo DRUG

Saline infusion will be administered for 14-24 hours

Also known as: Glycoprotein IIb/IIIa inhibitor

2

Eligibility Criteria

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

You may qualify if:

• All consecutive patients with stable or unstable troponin and CK-MB negative coronary artery disease showing aspirin and or clopidogrel resistance (ACR) will be enrolled. These include:
• Patients with clinical indication to undergo angiography for possible revascularisation.
• Patients with ACR in whom catheter-based coronary intervention is planned based on previous angiogram.

You may not qualify if:

• Patients who can not give informed consent or have a life expectancy of \< 1 year
• Evolving or Ongoing myocardial infarction (MI) (Persistence of or developing Q wave or ST segment elevation at ECG with or without typical chest pain or typical rapid rise and fall CK-MB or new LBBB) or patients in whom the treating physician intends to use a Gp IIB/IIIa inhibitors.
• Administration of any GP IIb/IIIa receptor antagonist, anticoagulation, or lytic therapy in the previous 30 days
• Serum creatinine more than 2.5 mg/dl (221 micromol/L)
• Ongoing bleeding or bleeding diathesis or contraindication for anticoagulation or increase bleeding risk or history of bleeding in the last 1 year
• Previous stroke or TIA or any intracranial pathology in the last six months
• Major surgery or trauma within the previous six weeks
• Platelet count \< 100.000 per cubic mm or HCT ,33% or Hb \< 11 gm/dL
• Subjects who received low-molecular-weight heparin within the 24 hours prior to randomization
• Subjects with an allergy or intolerance to aspirin, heparin, clopidogrel, or tirofiban
• Patients with severe hypertension (SBP \> 180 mm Hg or DBP \> 110 mm Hg) or in cardiogenic shock (SBP 80 mm Hg or below for \> 30 minutes) or requiring IABP

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead

Study Sites (1)

Cattedra di Cardiologia, Azienda Ospedaliera Universitaria di Ferrara

Ferrara, Fe, 44100, Italy

Location

Related Publications (3)

• Chen WH, Lee PY, Ng W, Tse HF, Lau CP. Aspirin resistance is associated with a high incidence of myonecrosis after non-urgent percutaneous coronary intervention despite clopidogrel pretreatment. J Am Coll Cardiol. 2004 Mar 17;43(6):1122-6. doi: 10.1016/j.jacc.2003.12.034.

  PMID: 15028378 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

• Valgimigli M, Campo G, de Cesare N, Meliga E, Vranckx P, Furgieri A, Angiolillo DJ, Sabate M, Hamon M, Repetto A, Colangelo S, Brugaletta S, Parrinello G, Percoco G, Ferrari R; Tailoring Treatment With Tirofiban in Patients Showing Resistance to Aspirin and/or Resistance to Clopidogrel (3T/2R) Investigators. Intensifying platelet inhibition with tirofiban in poor responders to aspirin, clopidogrel, or both agents undergoing elective coronary intervention: results from the double-blind, prospective, randomized Tailoring Treatment with Tirofiban in Patients Showing Resistance to Aspirin and/or Resistance to Clopidogrel study. Circulation. 2009 Jun 30;119(25):3215-22. doi: 10.1161/CIRCULATIONAHA.108.833236. Epub 2009 Jun 15.

  PMID: 19528337 DERIVED

MeSH Terms

Interventions

Tirofiban

Intervention Hierarchy (Ancestors)

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

Study Officials

• Marco Valgimigli, MD, PhD

  Università degli Studi di Ferrara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 9, 2006
• First Posted: November 10, 2006
• Study Start: May 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: May 1, 2011
• Last Updated: July 1, 2011

Record last verified: 2008-06

Locations

IT (1)