Ticagrelor in Remote Ischemic Preconditioning Study

NCT04174261 | Completed Phase 4 DMC

• 1 other identifier: ESR-14-10310
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 1

Brief Summary

Remote ischemic preconditioning (RIPC) reduces periprocedural myocardial injury (PMI) after percutaneous coronary intervention (PCI) through various pathways, including an adenosine-triggered pathway. Ticagrelor inhibits adenosine uptake, thus may potentiate the effects of RIPC. This randomized trial tested the hypothesis that ticagrelor potentiates the effect of RIPC and reduces PMI, as assessed by post-procedural troponin release

Conditions

Periprocedural Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• deltaTnI

  The primary outcome measure of the study was deltaTnI, defined as the difference between cardiac troponin I (cTnI) levels at 24 hours post-PCI and cTnI levels before the procedure.

  At the time of PCI / 24 hours post-PCI

Secondary Outcomes (3)

• Peri-procedural MI (type 4a MI)

  24 hours post-PCI

• Chest pain during PCI: analog 10-point scale

  During the PCI procedure

• ST-segment deviation during PCI

  During the PCI procedure

Other Outcomes (1)

• Bleeding

  At the time of PCI / 24 hours post-PCI

Study Arms (4)

Ticagrelor - Remote Ischemic Preconditioning

EXPERIMENTAL

Ticagrelor 180mg loading dose, and 90mg b.i.d thereafter. 3 cycles of 5-minute ischemia/5-minute reperfusion using a BP cuff around the non-dominant arm

Drug: Ticagrelor; Procedure: Remote Ischemic Preconditioning

Ticagrelor - Control

OTHER

Ticagrelor 180mg loading dose, and 90mg b.i.d thereafter. BP-cuff uninflated around the non-dominant arm

Drug: Ticagrelor

Clopidogrel - Remote Ischemic Preconditioning

ACTIVE COMPARATOR

Clopidogel 300mg loading dose, and 75mg q.d. thereafter. 3 cycles of 5-minute ischemia/5-minute reperfusion using a BP cuff around the non-dominant arm

Procedure: Remote Ischemic Preconditioning; Drug: Clopidogrel

Clopidogrel - Control

OTHER

Clopidogel 300mg loading dose, and 75mg q.d. thereafter. BP-cuff uninflated around the non-dominant arm

Drug: Clopidogrel

Interventions

Ticagrelor DRUG

Preprocedural ticagrelor loading and standard dose thereafter

Ticagrelor - Control; Ticagrelor - Remote Ischemic Preconditioning

Remote Ischemic Preconditioning PROCEDURE

Preprocedural remote ischemic preconditioning on the non-dominant arm

Clopidogrel - Remote Ischemic Preconditioning; Ticagrelor - Remote Ischemic Preconditioning

Clopidogrel DRUG

Preprocedural clopidogrel loading and standard dose thereafter

Clopidogrel - Control; Clopidogrel - Remote Ischemic Preconditioning

Eligibility Criteria

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

You may qualify if:

• Provision of informed consent prior to any study specific procedures
• Patients (Female and male) ≥ 18 of age
• Patients with NSTE-ACS undergoing coronary angiography, eligible for PCI

You may not qualify if:

• Women of childbearing potential
• Severe comorbidity (estimated life expectancy \<6 months)
• Baseline cTnI before PCI that is not stable or falling or is \> 5 ×99th percentile URL.
• End-stage renal disease(eGFR\<15 ml/min/1.73 m2)
• CRUSADE Bleeding Score \>50
• Patients with an indication for oral anticoagulation
• On maintenance therapy with ticagrelor or those that have received clopidogrel for less than 3 days
• Use of nicorandil or glibenclamide
• Concomitant theophylline/aminophylline use
• Known contraindications to the use of ticagrelor Hypersensitivity to the active substance or to any of the excipients
• Active pathological bleeding
• History of intracranial haemorrhage
• Moderate to severe hepatic impairment
• Co-administration of ticagrelor with strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir).
• Patients meeting criteria for immediate or early (\<24h) invasive strategy based on the current relevant European Society of Cardiology guidelines

Sponsors & Collaborators

• Hellenic Society of Interventional Cardiology: lead

Study Sites (1)

Athens Red Cross Hospital

Athens, Attica, 11526, Greece

Location

MeSH Terms

Interventions

Ticagrelor; Clopidogrel

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

• Apostolos Katsivas

  Head Cardiology Department, Athens Red Cross Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Patient randomization in the ticagrelor and the clopidogrel group took place using sealed, opaque envelopes containing a computer-generated randomization scheme. Using a similar procedure, patients were then randomly assigned to RIPC or no RIPC within 1 hour before the procedure.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The TRIP study was a randomized, assessor-blind, active comparator-controlled, clinical trial using a 2×2 factorial design, with 1:1 patient allocation to ticagrelor or clopidogrel and within each treatment a 1:1 allocation to RIPC or control.

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 22, 2019
• Study Start: January 29, 2017
• Primary Completion: December 18, 2017
• Study Completion: January 17, 2018
• Last Updated: November 22, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)