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

Phase 1

• 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; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-003621-33-ES
• Lead Sponsor: Fundación Interhospitalaria de Investigación Cardiovascular

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-03
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 50

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

? Prior myocardial infarction in the territory of the target vessel.
? Akinesia or dyskinesia in subtended myocardial segments.
? Severe impairment of left ventricular function (LVEF <35%).
? PCI target is a Chronic Total Occlusion.
? Target lesion has been treated previously (restenotic lesions).
? Target vessel is a saphenous vein graft or a surgical graft has been anastomosed to target vessel.
? TIMI flow ? 1 prior to guide wire crossing.
? Subject is not eligible for treatment with DES.
? Bleeding disorders or chronic anticoagulant treatment.
? Left main stenosis > 50%.
? Coronary surgery deemed more beneficial for the patient than PCI.
? Intolerance or contraindications to anti-platelet drugs.
? Contraindications for adenosine administration.
? Platelet count <75000 or >700000/mm3.
? Immunosuppressive therapy.
? Pregnant or breast feeding patient.
? History of intracranial haemorrhage.
? Severe hepatic impairment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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;<br> Timepoint(s) of evaluation of this end point: 1. Post PCI (just after stenting)<br> 2. Pre PCI (just before stenting)<br> ;<br> 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).<br> 2. Difference in microcirculatory resistance associated to the initiation of Ticagrelor treatment in DM or pre-DM (delta IMR-Pre-PCI).<br>

Secondary Outcome Measures

Name	Time	Method
<br> 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.<br> 2. Absolute IMR value after PCI in DM or pre-DM patients treated with Ticagrelor or Clopidogrel.<br> 3. Incidence (%) of severe microcirculatory impairment (IMR > 29) afer PCI in DM or pre-DM patients treated with Ticagrelor or Clopidogrel.<br> ;<br> Timepoint(s) of evaluation of this end point: 1. At discharge<br> 2. Post PCI<br> 3. Post PCI<br>