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

June 29, 2011 updated by: Università degli Studi di Ferrara

Tailoring Treatment With Tirofiban in Patients Showing Resistance to Aspirin and/or Resistance to Clopidogrel

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

263

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Fe
      • Ferrara, Fe, Italy, 44100
        • Cattedra di Cardiologia, Azienda Ospedaliera Universitaria di Ferrara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Glycoprotein IIb/IIIa inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Troponin I or T elevation ratio at least three times the upper limit of normal.
Time Frame: 48 hours
48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Bleeding rates
Time Frame: 30 days
30 days
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
30 days
Elevation of troponin levels above upper limit of normal in ratios different from the primary endpoint
Time Frame: within 30 days
within 30 days
Stent thrombosis
Time Frame: with the first year of follow-up
with the first year of follow-up
The rate of major adverse cardiovascular events
Time Frame: at 30 days and 1 year
at 30 days and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi di Ferrara

Investigators

  • Principal Investigator: Marco Valgimigli, MD, PhD, Università degli Studi di Ferrara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

November 9, 2006

First Submitted That Met QC Criteria

November 9, 2006

First Posted (Estimate)

November 10, 2006

Study Record Updates

Last Update Posted (Estimate)

July 1, 2011

Last Update Submitted That Met QC Criteria

June 29, 2011

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCA-01-III

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Angioplasty, Transluminal, Percutaneous Coronary

Clinical Trials on Tirofiban

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe