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

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

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

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

Intervention / Treatment
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* Drug: Clopidogrel
* Drug: Ticagrelor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clopidogrel<br>Clopidogrel 75 mg will be administered daily for 1 year | Drug: Clopidogrel<br> <br> |
| Experimental: Ticagrelor<br>Ticagrelor 90 mg will be administered daily for 1 year | Drug: Ticagrelor<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in increase of coronary blood flow (CBF) under adenosine administration from baseline in the coronary segment distal to the scaffold implanted immediately after CTO-PCI between the ticagrelor vs. clopidogrel group. |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in mean lumen diameter after nitrate administration in the coronary segment distal to the scaffold implanted immediately after CTO-PCI between the ticagrelor vs. clopidogrel group. |  | Baseline | 
| Changes from baseline in coronary flow reserve after adenosine administration in the coronary segment distal to the scaffold implanted immediately after CTO-PCI between the ticagrelor vs. clopidogrel group. |  | Baseline | 
| Changes from baseline in mean lumen diameter after nitrate administration in the coronary segment scaffolded by ABSORB and in that distal to it at 1 year follow-up between the ticagrelor vs. clopidogrel group. |  | 1 year | 
| Changes from baseline in coronary blood flow after adenosine administration in the coronary segment distal to the scaffold implanted at 1-year follow-up between the ticagrelor vs. clopidogrel group |  | 1 year | 
| Changes from baseline in coronary flow reserve after adenosine administration in the coronary segment distal to the scaffold implanted at 1-year follow-up between the ticagrelor vs. clopidogrel group. |  | 1 year | 
| Changes from baseline in mean lumen diameter after nitrate administration in the coronary segment scaffolded by ABSORB and in that distal to it at 3-year follow-up between the ticagrelor vs. clopidogrel group. |  | 3 years | 
| Changes from baseline in coronary blood flow after adenosine administration in the coronary segment distal to the scaffold implanted at 3-year follow-up between the ticagrelor vs. clopidogrel group. |  | 3 years | 
| Changes from baseline in coronary flow reserve after adenosine administration in the coronary segment distal to the scaffold implanted at 3-year follow-up between the ticagrelor vs. clopidogrel group. |  | 3 years | 
| Difference in intimal-media thickness at the site of scaffold implanted, evaluated by optical coherence tomography in a subgroup of patients at 1-year follow-up between the ticagrelor vs. clopidogrel group. |  | 1 year | 
| Difference in intimal-media thickness at the site of scaffold implanted, evaluated by optical coherence tomography at 3 years follow-up between the ticagrelor vs. clopidogrel group. |  | 3 years | 
| Clinical endpoints at 1 and 3 years follow-up: cardiac death, probable or definite scaffold thrombosis, target vessel failure, bleeding. |  | 1 and 3 years |