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

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

Tracking Information
First Submitted Date  ICMJE November 9, 2006
First Posted Date  ICMJE November 10, 2006
Last Update Posted Date July 1, 2011
Study Start Date  ICMJE May 2006
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2008)
Troponin I or T elevation ratio at least three times the upper limit of normal. [ Time Frame: 48 hours ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 9, 2006)
CK-MB elevation or Thrombotic Bail-out therapy after the start of PCI.
Change History Complete list of historical versions of study NCT00398463 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2008)
  • 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 ]
  • Elevation of troponin levels above upper limit of normal in ratios different from the primary endpoint [ Time Frame: within 30 days ]
  • Bleeding rates [ Time Frame: 30 days ]
  • Stent thrombosis [ Time Frame: with the first year of follow-up ]
  • The rate of major adverse cardiovascular events [ Time Frame: at 30 days and 1 year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2006)
the incidence of myocardial infarction defined as elevation of CK-MB ≥3 or ≥5 times the ULN or cTnI elevation more than 1 ug/ml or a value that is at least 50 % above the last pre-procedural levels in one or more blood sample(s).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Tirofiban Administration in Patients With Aspirin and or Clopidogrel Resistance
Official Title  ICMJE Tailoring Treatment With Tirofiban in Patients Showing Resistance to Aspirin and/or Resistance to Clopidogrel
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Angioplasty, Transluminal, Percutaneous Coronary
Intervention  ICMJE
  • Drug: Tirofiban
    Tirofiban infusion given as high bolus dose plus standard 14-24 hour infusion
    Other Name: Glycoprotein IIb/IIIa inhibitor
  • Drug: Placebo
    Saline infusion will be administered for 14-24 hours
    Other Name: Glycoprotein IIb/IIIa inhibitor
Study Arms  ICMJE
  • Experimental: 1
    Aspirin, clopidogrel, Unfractioned heparin or bivalirudin plus tirofiban infusion given at high bolus dose
    Intervention: Drug: Tirofiban
  • Placebo Comparator: 2
    Aspirin, clopidogrel, Unfractioned heparin or bivalirudin plus placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 14, 2008)
263
Original Enrollment  ICMJE
 (submitted: November 9, 2006)
200
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00398463
Other Study ID Numbers  ICMJE TCA-01-III
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marco Valgimigli, Azienda Ospedaliera Universitaria di Ferrara
Study Sponsor  ICMJE Università degli Studi di Ferrara
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marco Valgimigli, MD, PhD Università degli Studi di Ferrara
PRS Account Università degli Studi di Ferrara
Verification Date June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP