TIcaGrEloR and ABSORB Bioresorbable Vascular Scaffold Implantation for Recovery of Vascular Function After Successful Chronic Total Occlusion Recanalization

• Status: Completed
• Trial end date: 2019-06-12
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Clinic of Barcelona
• Collaborator: AstraZeneca
• Treatments: Clopidogrel; Ticagrelor

Criteria

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