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Clinical Trials/EUCTR2015-003621-33-ES
EUCTR2015-003621-33-ES
Active, Not Recruiting
Phase 1

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

Fundación Interhospitalaria de Investigación Cardiovascular0 sites50 target enrollmentFebruary 3, 2016
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ConditionsIschemic Heart Disease in Diabetic patientsMedDRA version: 18.1 Level: PT Classification code 10072685 Term: Microvascular coronary artery disease System Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
DrugsBriliquePlavix

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Ischemic Heart Disease in Diabetic patients
Sponsor
Fundación Interhospitalaria de Investigación Cardiovascular
Enrollment
50
Status
Active, Not Recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 3, 2016
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Fundación Interhospitalaria de Investigación Cardiovascular

Eligibility 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

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%.

Outcomes

Primary Outcomes

Not specified

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