PRotective Effect on the Coronary Microcirculation of Patients With DIabetes by Clopidogrel or Ticagrelor

• Status: Unknown status
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether Ticagrelor has a protective effect on microcirculation during percutaneous coronary interventions in patients with Diabetes mellitus type II or in a pre-diabetic status.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion Investigacion Interhospitalaria Cardiovascular
• Collaborator: AstraZeneca
• Treatments: Clopidogrel; Ticagrelor; Ticlopidine

Criteria

Inclusion Criteria:

• Subject with Diabetes Mellitus (DM) Type II

• 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, and PCI target(s) have FFR≤0.80

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

• Thrombolisis in Myocardial Infarction (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