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Study of Tirofiban Administration in Patients With Aspirin and or Clopidogrel Resistance (3T/2R)

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: NCT00398463
Recruitment Status : Completed
First Posted : November 10, 2006
Last Update Posted : July 1, 2011
Information provided by:
Università degli Studi di Ferrara

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.

Condition or disease Intervention/treatment Phase
Angioplasty, Transluminal, Percutaneous Coronary Drug: Tirofiban Drug: Placebo Phase 4

Detailed Description:

This study will investigate the effect of treatment with a high bolus dosage of Tirofiban (in addition to Aspirin, Heparin and 300mg or 600mg clopidogrel) on the rate of periprocedural myocardial infarction compared to Aspirin, Heparin (or bivalirudin) and 300mg or 600mg clopidogrel alone in patients resistant to aspirin and/or to clopidogrel.

This is a randomized, double blind, placebo controlled (with bailout tirofiban as rescue) multicenter study. Enrollment will last between 12 and 36 months depending on the final number of participating centres. The minimum follow-up will be 30 days after the index procedure.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 263 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tailoring Treatment With Tirofiban in Patients Showing Resistance to Aspirin and/or Resistance to Clopidogrel
Study Start Date : May 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Aspirin, clopidogrel, Unfractioned heparin or bivalirudin plus tirofiban infusion given at high bolus dose
Drug: Tirofiban
Tirofiban infusion given as high bolus dose plus standard 14-24 hour infusion
Other Name: Glycoprotein IIb/IIIa inhibitor

Placebo Comparator: 2
Aspirin, clopidogrel, Unfractioned heparin or bivalirudin plus placebo
Drug: Placebo
Saline infusion will be administered for 14-24 hours
Other Name: Glycoprotein IIb/IIIa inhibitor

Primary Outcome Measures :
  1. Troponin I or T elevation ratio at least three times the upper limit of normal. [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. 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). [ Time Frame: 30 days ]
  2. Elevation of troponin levels above upper limit of normal in ratios different from the primary endpoint [ Time Frame: within 30 days ]
  3. Bleeding rates [ Time Frame: 30 days ]
  4. Stent thrombosis [ Time Frame: with the first year of follow-up ]
  5. The rate of major adverse cardiovascular events [ Time Frame: at 30 days and 1 year ]

Information from the National Library of Medicine

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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:

  1. All Patients older than 18 years scheduled for coronary angiography and/or PCI will be enrolled. [Patients should be CK-MB negative (to avoid CK washout with revascularization) and also cTnI/T negative whereas other high-risk features will not lead to patient exclusion.
  2. 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.

Exclusion Criteria:

  1. Patients who can not give informed consent or have a life expectancy of < 1 year
  2. 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.
  3. Administration of any GP IIb/IIIa receptor antagonist, anticoagulation, or lytic therapy in the previous 30 days
  4. Serum creatinine more than 2.5 mg/dl (221 micromol/L)
  5. Ongoing bleeding or bleeding diathesis or contraindication for anticoagulation or increase bleeding risk or history of bleeding in the last 1 year
  6. Previous stroke or TIA or any intracranial pathology in the last six months
  7. Major surgery or trauma within the previous six weeks
  8. Platelet count < 100.000 per cubic mm or HCT ,33% or Hb < 11 gm/dL
  9. Subjects who received low-molecular-weight heparin within the 24 hours prior to randomization
  10. Subjects with an allergy or intolerance to aspirin, heparin, clopidogrel, or tirofiban
  11. 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

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): NCT00398463

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Cattedra di Cardiologia, Azienda Ospedaliera Universitaria di Ferrara
Ferrara, Fe, Italy, 44100
Sponsors and Collaborators
Università degli Studi di Ferrara
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Principal Investigator: Marco Valgimigli, MD, PhD Università degli Studi di Ferrara
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Marco Valgimigli, Azienda Ospedaliera Universitaria di Ferrara Identifier: NCT00398463    
Other Study ID Numbers: TCA-01-III
First Posted: November 10, 2006    Key Record Dates
Last Update Posted: July 1, 2011
Last Verified: June 2008
Keywords provided by Università degli Studi di Ferrara:
aspirin resistance
clopidogrel resistance
Additional relevant MeSH terms:
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Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Interferon Inducers
Radiation-Protective Agents
Protective Agents