TIcaGrEloR and ABSORB Bioresorbable Vascular Scaffold Implantation for Recovery of Vascular Function After Successful Chronic Total Occlusion Recanalization (TIGER-BVS)

Hospital Clinic of Barcelona

Status and phase

Completed

Phase 4

Conditions

Patients Who Are Scheduled to Undergo a PCI (Percutaneous Coronary Intervention) for CTO (Chronic Total Occlusion)

Treatments

Drug: Clopidogrel

Drug: Ticagrelor

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02211066

2013-002675-17 (EudraCT Number)

TIGER-BVS

Details and patient eligibility

About

The study is a single-centre, randomized, active controlled, open label clinical trial. The primary hypothesis is that ticagrelor will show superiority over clopidogrel immediately after CTO-PCI (chronic total occlusion - percutaneous coronary intervention)

Full description

The hypothesis is tested in the first randomization. Both antiplatelet therapy will be used in both arms at the approved doses and for the approved duration therapy of 1-year. The secondary hypothesis will test the role of ticagrelor/clopidogrel alone and together with ABSORB BVS implantation in the recovery of vascular function at long-term. This hypothesis is tested in the second randomization. The angiographic follow-up will be scheduled at 1 or 3-year follow-up in order to test the secondary hypothesis either at the moment of the end of the antiplatelet therapy or at the moment of scaffold bioresorption.

Enrollment

59 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients of both sexes, older than 18 years old.
Written informed consent obtained.
Patients with stable angina pectoris (Canadian Cardiovascular Society (CCS) Class 1, 2, 3 or 4) or patients with documented silent ischemia by stress test during the last year.
Patients eligible for coronary revascularization in a coronary chronic total occlusion, which was angiographically documented in a previous coronary angiography during the last year.

Exclusion criteria

Women who are pregnant or women of childbearing potential who do not use adequate contraception.
Known allergies to aspirin, clopidogrel bisulfate (Plavix ®), ticagrelor (BriliqueTM) heparin, or a sensitivity to contrast media, which cannot be adequately pre-medicated.
Participation in other studies.
Life expectancy of less than one year or factors making clinical and/or angiographic follow-up difficult.
Planned cardiac surgery or major non-cardiac surgery.
The subject has a history of bleeding diathesis or coagulopathy.
The subject suffered disabling stroke within the past year.
Known major hematologic, neoplastic, metabolic, gastrointestinal or endocrine dysfunction, which, in the judgment of the Investigator, may affect the patient's ability to complete the study.
History of malignancy, except in patients who have been disease-free >5 years or whose only malignancy has been basal or squamous cell skin carcinoma.
Inability to provide informed consent