TIcagrelor in Rotational Atherectomy to Reduce TROPonin Enhancement

NCT02505399 | Completed Phase 4

• 1 other identifier: RC31/14/7445
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 4

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.

Conditions

Atherosclerosis

Keywords

Rotational Atherectomy; clopidogrel; thrombosis; ticagrelor

Outcome Measures

Primary Outcomes (1)

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

  Troponin kinetics during the first 24 hours following rotational atherectomy.

  up to 24 hours

Secondary Outcomes (2)

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

  up to 36 hours

• Frequence of clinical events during the in-hospital period

  One day before the procedure until 36 hours after.

Study Arms (2)

ticagrelor

EXPERIMENTAL

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).

Drug: ticagrelor

clopidogrel

ACTIVE COMPARATOR

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).

Drug: clopidogrel

Interventions

ticagrelor DRUG

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).

Also known as: ticagrelor per os

ticagrelor

clopidogrel DRUG

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).

Also known as: clopidrogel per os

clopidogrel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (4)

Clinique Pasteur

Toulouse, Haute-Garonne, 31000, France

Location

Fédération de Cardiologie CHU TOULOUSE

Toulouse, Haute-Garonne, 31059, France

Location

Hospices civils de Lyon

Lyon, 69000, France

Location

University Hospital

Nîmes, 30000, France

Location

Related Publications (1)

• Lhermusier T, Motreff P, Bataille V, Cayla G, Farah B, Roncalli J, Elbaz M, Boudou N, Campello-Parada F, Bouisset F, Souteyrand G, Berard E, Bongard V, Carrie D. TIcagrelor in Rotational Atherectomy to Reduce TROPonin Enhancement: The TIRATROP Study, A Randomized Controlled Trial. J Clin Med. 2023 Feb 11;12(4):1445. doi: 10.3390/jcm12041445.

  PMID: 36835980 RESULT

MeSH Terms

Conditions

Atherosclerosis; Thrombosis

Interventions

Ticagrelor; Clopidogrel

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Didier Didier, PHD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: July 22, 2015
• Study Start: November 1, 2015
• Primary Completion: May 24, 2018
• Study Completion: May 30, 2018
• Last Updated: December 5, 2025

Record last verified: 2018-12

Locations

FR (4)