Protective effect of antiplatelet drug "Ticagrelor" compared to antiplatelet drug "Clopidogrel" on small heart vessels in diabetic patient with angina

PRotective Effect on the coronary microcirculation of patients with DIabetes by Clopidogrel or Ticagrelor:A randomized multicenter clinical trial using intracoronary multimodal physiology - PREDICT

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003621-33-ES

Enrollment

Registered

2016-02-03

Start date

2016-02-25

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Heart Disease in Diabetic patients MedDRA version: 18.1 Level: PT Classification code 10072685 Term: Microvascular coronary artery disease System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: Brilique Product Name: Brilique Product Code: Brilique Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Ticagrel

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Subject with Diabetes Mellitus Type II or pre-Diabetes Mellitus Type II status. ? Subject must be older than 18 years. ? Written informed consent available. ?Subject with stable ischemic heart disease referred for coronary angiography. ? Subject is eligible for PCI. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35

Exclusion criteria

Exclusion criteria: ? Prior myocardial infarction in the territory of the target vessel. ? Akinesia or dyskinesia in subtended myocardial segments. ? Severe impairment of left ventricular function (LVEF 50%. ? Coronary surgery deemed more beneficial for the patient than PCI. ? Intolerance or contraindications to anti-platelet drugs. ? Contraindications for adenosine administration. ? Platelet count 700000/mm3. ? Immunosuppressive therapy. ? Pregnant or breast feeding patient. ? History of intracranial haemorrhage. ? Severe hepatic impairment.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the protective effect of Ticagrelor on microcirculation during Percutaneous Coronary Intervention (PCI) in patients with Diabetes Mellitus (DM) or pre-DM;Secondary Objective: Not applicable; Timepoint(s) of evaluation of this end point: 1. Post PCI (just after stenting) 2. Pre PCI (just before stenting) ; Primary end point(s): 1. Difference in microcirculatory resistance associated to PCI in DM or pre-DM patients treated with Ticagrelor or Clopidogrel (delta IMR-Post-PCI). 2. Difference in microcirculatory resistance associated to the initiation of Ticagrelor treatment in DM or pre-DM (delta IMR-Pre-PCI).	—

Measure

Time frame

Main Objective: To investigate the protective effect of Ticagrelor on microcirculation during Percutaneous Coronary Intervention (PCI) in patients with Diabetes Mellitus (DM) or pre-DM;Secondary Objective: Not applicable; Timepoint(s) of evaluation of this end point: 1. Post PCI (just after stenting) 2. Pre PCI (just before stenting) ; Primary end point(s): 1. Difference in microcirculatory resistance associated to PCI in DM or pre-DM patients treated with Ticagrelor or Clopidogrel (delta IMR-Post-PCI). 2. Difference in microcirculatory resistance associated to the initiation of Ticagrelor treatment in DM or pre-DM (delta IMR-Pre-PCI).

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Secondary

Measure	Time frame
Secondary end point(s): 1. Myocardial necrosis associated to PCI damage, as assessed by cardiac markers in DM or pre-DM patients treated with Ticagrelor or Clopidogrel. 2. Absolute IMR value after PCI in DM or pre-DM patients treated with Ticagrelor or Clopidogrel. 3. Incidence (%) of severe microcirculatory impairment (IMR > 29) afer PCI in DM or pre-DM patients treated with Ticagrelor or Clopidogrel. ; Timepoint(s) of evaluation of this end point: 1. At discharge 2. Post PCI 3. Post PCI	—

Measure

Time frame

Secondary end point(s): 1. Myocardial necrosis associated to PCI damage, as assessed by cardiac markers in DM or pre-DM patients treated with Ticagrelor or Clopidogrel. 2. Absolute IMR value after PCI in DM or pre-DM patients treated with Ticagrelor or Clopidogrel. 3. Incidence (%) of severe microcirculatory impairment (IMR > 29) afer PCI in DM or pre-DM patients treated with Ticagrelor or Clopidogrel. ; Timepoint(s) of evaluation of this end point: 1. At discharge 2. Post PCI 3. Post PCI

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Countries

Spain

Contacts

Public ContactUnidad de Hemodinámica

Hospital Clinico San Carlos

javier.escaned@salud.madrid.org+34913303438

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026