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TIcagrelor in Rotational Atherectomy to Reduce TROPonin Enhancement

NCT02505399 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-12-05

No results posted yet for this study

Summary

Rotational atherectomy (RA) prior to angioplasty is the reference treatment for highly calcified atherosclerotic coronary lesions. It aims at fragmenting calcium deposits into microscopic particulates to allow less hazardous coronary revascularization and stenting. The main drawback associated with the procedure is the subsequent enhancement of platelet aggregation which promotes the distal embolization of micro-thrombi and atherosclerotic fragments. In order to limit these complications, a double antiplatelet therapy is required (generally Clopidogrel + Aspirin) when RA procedures are performed. Clopidogrel inhibits the protein P2Y12 which is a cornerstone in platelet aggregation. Ticagrelor is a new antiplatelet agent that provides faster and greater P2Y12 inhibition than Clopidogrel. It is currently indicated to reduce risk of cardiovascular events in patients hospitalized for coronary revascularization after an acute coronary syndrome. Ticagrelor has never been evaluated so far in stable coronary patients treated with rotational atherectomy prior to angioplasty.

Conditions

Interventions

DRUG

ticagrelor

Ticagrelor will be administered orally, according to the following scheme: * 180 mg the evening preceding (and at least 6 hours before) rotational atherectomy (Day -1), * 90 mg the following morning (D Day before rotational atherectomy and angioplasty), * 90 mg the following evening (D Day after rotational atherectomy and angioplasty), * 90 mg twice daily the day after the procedure of rotational atherectomy and angioplasty (Day +1).

DRUG

clopidogrel

Clopidogrel will be administered orally, according to the following scheme: * 300 mg the evening preceding (and at least 6 hours before) rotational atherectomy (Day -1), * 75 mg the following morning (D Day before rotational atherectomy and angioplasty), * 0 mg the following evening (D Day after rotational atherectomy and angioplasty), * 75 mg once daily the day after the procedure of rotational atherectomy and angioplasty (Day +1).

Sponsors & Collaborators

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Didier Didier, PHD · University Hospital, Toulouse

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2018-05-24
Completion
2018-05-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02505399 on ClinicalTrials.gov