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Ticagrelor And PrEconditioning in Patients With coronaRy Artery diSease

NCT02701140 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2020-11-16

No results posted yet for this study

Summary

The aim of this study is to assess the pleiotropic effects of ticagrelor that could represent possible mechanisms for its beneficial effects on cardiovascular mortality. We will test three different hypotheses:

1. Ticagrelor may increase ischemic preconditioning as compared to clopidogrel in patients with stable coronary disease, showing multivessel coronary artery disease and undergoing staged PCI.
2. Ticagrelor may improve microvascular perfusion in the myocardium of patients with multivessel coronary artery disease undergoing staged PCI.
3. Ticagrelor may exert positive effects enhancing the paracrine modulation, migration, homing and survival of hBMDSC, with a potential impact on the microvascular dysfunction and on the protective response to ischemia (cellular preconditioning).

Conditions

  • Myocardial Ischemia

Interventions

PROCEDURE

Coronary stenting

Within 1h after the first PCI, patients will be randomized to either ticagrelor or clopidogrel.

PROCEDURE

intracoronary ECG recording

Measurement of ST segment elevation using intracoronary ECG recording

PROCEDURE

Coronary Flow reserve

measured with an intracoronary pressure/temperature sensor-tipped guidewire

PROCEDURE

Index of Microcirculatory Resistance

measured with an intracoronary pressure/temperature sensor-tipped guidewire

PROCEDURE

Fractional Flow Reserve

measurement of Fractional Flow Reserve during hyperemic phase.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Italo Porto

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2020-11-30
Completion
2020-11-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Companies

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 NCT02701140 on ClinicalTrials.gov