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

This study has been completed.
Sponsor:
Information provided by:
Università degli Studi di Ferrara
ClinicalTrials.gov Identifier:
NCT00398463
First received: November 9, 2006
Last updated: June 29, 2011
Last verified: June 2008
History of Changes
  Purpose

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 Intervention Phase
Angioplasty, Transluminal, Percutaneous Coronary
 Drug: Tirofiban
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tailoring Treatment With Tirofiban in Patients Showing Resistance to Aspirin and/or Resistance to Clopidogrel

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Università degli Studi di Ferrara:

Primary Outcome Measures:
  • Troponin I or T elevation ratio at least three times the upper limit of normal. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Elevation of troponin levels above upper limit of normal in ratios different from the primary endpoint [ Time Frame: within 30 days ] [ Designated as safety issue: No ]
  • Bleeding rates [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: with the first year of follow-up ] [ Designated as safety issue: Yes ]
  • The rate of major adverse cardiovascular events [ Time Frame: at 30 days and 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 263
Study Start Date: May 2006
Study Completion Date: May 2011
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00398463

Locations
Italy
Cattedra di Cardiologia, Azienda Ospedaliera Universitaria di Ferrara
Ferrara, Fe, Italy, 44100
Sponsors and Collaborators
Università degli Studi di Ferrara
Investigators
Principal Investigator: Marco Valgimigli, MD, PhD Università degli Studi di Ferrara
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Marco Valgimigli, Azienda Ospedaliera Universitaria di Ferrara
ClinicalTrials.gov Identifier: NCT00398463     History of Changes
Other Study ID Numbers: TCA-01-III
Study First Received: November 9, 2006
Last Updated: June 29, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by Università degli Studi di Ferrara:
tirofiban
aspirin resistance
clopidogrel resistance

Additional relevant MeSH terms:
Aspirin
Tirofiban
Clopidogrel
Krestin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
 Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Adjuvants, Immunologic
Immunologic Factors

ClinicalTrials.gov processed this record on May 21, 2013