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

Angioplasty, Transluminal, Percutaneous Coronary Clinical Trial

— 3T/2R  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00398463
• Other study ID #: TCA-01-III
• Status: Completed
• Phase: Phase 4
• First received: November 9, 2006
• Last updated: June 29, 2011
• Start date: May 2006
• Est. completion date: May 2011

Study information

• Verified date: June 2008
• Source: Università degli Studi di Ferrara
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: May 2011
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angioplasty, Transluminal, Percutaneous Coronary

Intervention

Drug:
• Tirofiban
Tirofiban infusion given as high bolus dose plus standard 14-24 hour infusion
• Placebo
Saline infusion will be administered for 14-24 hours

Locations

Country	Name	City	State
Italy	Cattedra di Cardiologia, Azienda Ospedaliera Universitaria di Ferrara	Ferrara	Fe

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Ferrara

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Troponin I or T elevation ratio at least three times the upper limit of normal.		48 hours	No
Secondary	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	No
Secondary	Elevation of troponin levels above upper limit of normal in ratios different from the primary endpoint		within 30 days	No
Secondary	Bleeding rates		30 days	Yes
Secondary	Stent thrombosis		with the first year of follow-up	Yes
Secondary	The rate of major adverse cardiovascular events		at 30 days and 1 year	Yes