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TIcagrelor in Rotational Atherectomy to Reduce TROPonin Enhancement (TIRATROP)

Primary Purpose

Atherosclerosis

Status

Completed

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

ticagrelor

clopidogrel

About this trial

This is an interventional prevention trial for Atherosclerosis focused on measuring Rotational Atherectomy, clopidogrel, thrombosis, ticagrelor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria :

Stable coronary patient, or patient presenting with a non ST-elevation acute coronary syndrome without troponin elevation, or with troponin back to normal,
Patient treated with a combination of Aspirin + Clopidogrel before hospitalization at the study center,
Patient with at least one highly calcified coronary lesion eligible for rotational atherectomy prior to angioplasty,
Patient agreed to participate after full information on the study.

Exclusion criteria :

Acute coronary syndrome with ST-elevation,
Plasma troponin level higher than 3 times the upper limit of the laboratory,
Lesion located on a coronary bypass,
Coronary thrombus diagnosed by angiography,
Coronary dissection diagnosed by angiography,
Left ventricular ejection fraction lower than 30%,
Contra-indication to use Ticagrelor or Clopidogrel as listed in the Summary of Product Characteristics (SmPC, annex 1 & 2):
- Known hypersensitivity to the active substance or to the excipients,
- Active pathological bleeding,
- History of intracranial hemorrhage,
- Moderate to severe hepatic impairment,
- Co-administration with a strong cytochrome P450 3A4 inhibitor (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir),
Other conditions at increased risk of bleeding:
- Congenital or acquired coagulation disorder
- Gastroduodenal bleeding within past 6 months,
- Recent major trauma or surgery within past 30 days,
- Concomitant use of fibrinolytics, oral anticoagulation, non-steroidal antiinflammatory drugs,
Significant anemia,
Increased risk of bradycardia,
History of asthma or Chronic Obstructive Pulmonary Disease,
Uric acid nephropathy,
Ischemic stroke within 7 days,
Heredity galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption,
Concomitant use of a strong CYP3A4 inducer
Concomitant use of CYP3A4 substrates with narrow therapeutic indices (e.g. cisapride, ergot alkaloids), simvastatin at a dose greater than 40 mg/d,
Concomitant use of Selective Serotonin Reuptake inhibitors,
Concomitant use of digoxin without close clinical and laboratory monitoring,
Contra-indication to use Aspirin,
Breast-feeding,
Pregnancy,
Adult protected by the law,
Patient participating in another biomedical research.

Sites / Locations

Clinique Pasteur
Fédération de Cardiologie CHU TOULOUSE
Hospices civils de Lyon
University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ticagrelor

clopidogrel

Arm Description

In the intervention group, 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).

In the control group, 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).

Outcomes

Primary Outcome Measures

area under the curve corresponding to troponin level as a function of time

Troponin kinetics during the first 24 hours following rotational atherectomy.

Secondary Outcome Measures

area under the curve corresponding to troponin level as a function of time

Frequence of clinical events during the in-hospital period

Major life-threatening bleeding Minor bleeding leading to clinically significant disability Death from any cause, Acute coronary syndrome with or without ST elevation, Ischemic stroke, In-stent thrombosis, Coronary dissection or perforation, Bail-out requiring anti GPIIb-IIIa administration.

Full Information

NCT ID

NCT02505399

First Posted

June 3, 2015

Last Updated

December 18, 2018

Sponsor

University Hospital, Toulouse

1. Study Identification

Unique Protocol Identification Number

NCT02505399

Brief Title

TIcagrelor in Rotational Atherectomy to Reduce TROPonin Enhancement

Acronym

TIRATROP

Official Title

TIcagrelor in Rotational Atherectomy to Reduce TROPonin Enhancement: the TIRATROP Study, a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

November 2015 (undefined)

Primary Completion Date

May 24, 2018 (Actual)

Study Completion Date

May 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Toulouse

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed Description

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. It is characterized by a slow and variable transformation of a prodrug into an active metabolite and by a remaining risk of thrombosis and myocardial infarction. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atherosclerosis

Keywords

Rotational Atherectomy, clopidogrel, thrombosis, ticagrelor

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

180 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ticagrelor

Arm Type

Experimental

Arm Description

Arm Title

clopidogrel

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

ticagrelor

Other Intervention Name(s)

ticagrelor per os

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

clopidogrel

Other Intervention Name(s)

clopidrogel per os

Intervention Description

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).

Primary Outcome Measure Information:

Title

area under the curve corresponding to troponin level as a function of time

Description

Troponin kinetics during the first 24 hours following rotational atherectomy.

Time Frame

up to 24 hours

Secondary Outcome Measure Information:

Title

area under the curve corresponding to troponin level as a function of time

Time Frame

up to 36 hours

Title

Frequence of clinical events during the in-hospital period

Description

Time Frame

One day before the procedure until 36 hours after.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria : Stable coronary patient, or patient presenting with a non ST-elevation acute coronary syndrome without troponin elevation, or with troponin back to normal, Patient treated with a combination of Aspirin + Clopidogrel before hospitalization at the study center, Patient with at least one highly calcified coronary lesion eligible for rotational atherectomy prior to angioplasty, Patient agreed to participate after full information on the study. Exclusion criteria : Acute coronary syndrome with ST-elevation, Plasma troponin level higher than 3 times the upper limit of the laboratory, Lesion located on a coronary bypass, Coronary thrombus diagnosed by angiography, Coronary dissection diagnosed by angiography, Left ventricular ejection fraction lower than 30%, Contra-indication to use Ticagrelor or Clopidogrel as listed in the Summary of Product Characteristics (SmPC, annex 1 & 2): Known hypersensitivity to the active substance or to the excipients, Active pathological bleeding, History of intracranial hemorrhage, Moderate to severe hepatic impairment, Co-administration with a strong cytochrome P450 3A4 inhibitor (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir), Other conditions at increased risk of bleeding: Congenital or acquired coagulation disorder Gastroduodenal bleeding within past 6 months, Recent major trauma or surgery within past 30 days, Concomitant use of fibrinolytics, oral anticoagulation, non-steroidal antiinflammatory drugs, Significant anemia, Increased risk of bradycardia, History of asthma or Chronic Obstructive Pulmonary Disease, Uric acid nephropathy, Ischemic stroke within 7 days, Heredity galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption, Concomitant use of a strong CYP3A4 inducer Concomitant use of CYP3A4 substrates with narrow therapeutic indices (e.g. cisapride, ergot alkaloids), simvastatin at a dose greater than 40 mg/d, Concomitant use of Selective Serotonin Reuptake inhibitors, Concomitant use of digoxin without close clinical and laboratory monitoring, Contra-indication to use Aspirin, Breast-feeding, Pregnancy, Adult protected by the law, Patient participating in another biomedical research.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Didier Didier, PHD

Organizational Affiliation

CHU Toulouse

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinique Pasteur

City

Toulouse

State/Province

Haute-Garonne

ZIP/Postal Code

31000

Country

France

Facility Name

Fédération de Cardiologie CHU TOULOUSE

City

Toulouse

State/Province

Haute-Garonne

ZIP/Postal Code

31059

Country

France

Facility Name

Hospices civils de Lyon

City

Lyon

ZIP/Postal Code

69000

Country

France

Facility Name

University Hospital

City

Nîmes

ZIP/Postal Code

30000

Country

France

12. IPD Sharing Statement

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TIcagrelor in Rotational Atherectomy to Reduce TROPonin Enhancement

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