The use of antiplatelet drug (Ticagrelor) and bioresorbable coronary stent in recovery of vascular function after successful coronary recanalization.

Ticagrelor and absorb bioresorbable vascular scaffold implantation for recovery of vascular function after successful chronic total occlusion recanalization - TIGER-BVS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002675-17-ES

Enrollment

100

Registered

2014-05-22

Start date

2014-05-30

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic total coronary occlusion

Interventions

Trade Name: Brilique Product Name: Brilique Product Code: Brilique Pharmaceutical Form: Tablet INN or Proposed INN: Ticagrelor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a.Patients of both sexes, more than 18 years old. b. Written informed consent obtained. c. 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. d. Patients eligible for coronary revascularization in a coronary chronic total occlusion, which was angiographically documented in a previous coronary angiography during the last year. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: a. Women who are pregnant or women of childbearing potential who do not use adequate contraception. b. Known allergies to aspirin, clopidogrel bisulfate (Plavix ®), ticagrelor (BriliqueTM) heparin, or a sensitivity to contrast media, which cannot be adequately pre-medicated. c. Participation in other studies. d. Life expectancy of less than one year or factors making clinical and/or angiographic follow-up difficult. e. Planned cardiac surgery or major non-cardiac surgery. f. The subject has a history of bleeding diathesis or coagulopathy. g. The subject suffered disabling stroke within the past year. h. 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. i. 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. j. Inability to provide informed consent.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the effects of ticagrelor vs. clopidogrel on the adenosine-induced physiological vascular function of the coronary segment distal to a coronary chronic total occlusion immediately after percutaneous recanalization.; Secondary Objective: 1) To determine the effects of ticagrelor vs. clopidogrel on the nitrates-dependent vascular function of the coronary segment distal to a coronary chronic total occlusion immediately after its percutaneous recanalization 2) To determine the effect of ticagrelor vs. clopidogrel on the adenosine and nitrate-dependent vascular function on the coronary segment scaffolded by ABSORB BVS and of that distal to it at 1-year follow-up 3) To determine the effect of ticagrelor vs. clopidogrel on the adenosine and nitrate-dependent vascular function on the coronary segment scaffolded by ABSORB BVS and of that distal to it at 3-year follow-up 4) To determine the effect of ABSORB BVS implantation on the recovery of vascular morphology and function at 1-year follow-up 5) To determine the effect of ABSORB BVS implantation on the recovery of vascular morphology and function at 3-year follow-up ;Primary end point(s): Differences in increase of coronary blood flow (CBF) under adenosine administration in the coronary segment distal to the scaffold implanted immediately after CTO-PCI between the ticagrelor vs. clopidogrel group.;Timepoint(s) of evaluation of this end point: 1 and 3 years	—

Measure

Time frame

Main Objective: To determine the effects of ticagrelor vs. clopidogrel on the adenosine-induced physiological vascular function of the coronary segment distal to a coronary chronic total occlusion immediately after percutaneous recanalization.; Secondary Objective: 1) To determine the effects of ticagrelor vs. clopidogrel on the nitrates-dependent vascular function of the coronary segment distal to a coronary chronic total occlusion immediately after its percutaneous recanalization 2) To determine the effect of ticagrelor vs. clopidogrel on the adenosine and nitrate-dependent vascular function on the coronary segment scaffolded by ABSORB BVS and of that distal to it at 1-year follow-up 3) To determine the effect of ticagrelor vs. clopidogrel on the adenosine and nitrate-dependent vascular function on the coronary segment scaffolded by ABSORB BVS and of that distal to it at 3-year follow-up 4) To determine the effect of ABSORB BVS implantation on the recovery of vascular morphology and function at 1-year follow-up 5) To determine the effect of ABSORB BVS implantation on the recovery of vascular morphology and function at 3-year follow-up ;Primary end point(s): Differences in increase of coronary blood flow (CBF) under adenosine administration in the coronary segment distal to the scaffold implanted immediately after CTO-PCI between the ticagrelor vs. clopidogrel group.;Timepoint(s) of evaluation of this end point: 1 and 3 years

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Secondary

Measure	Time frame
Secondary end point(s): 1. 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. 2. 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. 3. 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. 4. 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. 5. 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. 6. 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. ;Timepoint(s) of evaluation of this end point: 1 and 3 years	—

Measure

Time frame

Secondary end point(s): 1. 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. 2. 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. 3. 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. 4. 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. 5. 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. 6. 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. ;Timepoint(s) of evaluation of this end point: 1 and 3 years

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Countries

Spain

Contacts

Public ContactServicio de Cardología

Hospital Clínic de Barcelona

sabrugal@clinic.ub.es00349322754002042

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026