EUCTR2014-005363-33-NL
Active, not recruiting
Phase 1
Reducing Micro Vascular dysfunction In revascularized STEMI patients by off-target properties of ticagrelor - REDUCE-MVI
VU university medical center0 sites110 target enrollmentApril 16, 2015
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- ST elevation myocardial infarction (STEMI)
- Sponsor
- VU university medical center
- Enrollment
- 110
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Provision of informed consent
- •2\.Patients presenting with STEMI \<12 hours
- •3\.Successful PCI of the infarct\-related vessel with a modern DES
- •4\.Intermediate stenosis in non\-infarct\-related vessel (50\-90%)
- •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 70
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 40
Exclusion Criteria
- •1\.history of myocardial infarction
- •2\.Participation in another clinical study with an investigational product during the preceding 30 days
- •3\.history of cerebrovascular accident (CVA) or 'transient ischaemic attack' (TIA)
- •4\.History of intracranial haemorrhage
- •5\.indication or use of oral anticoagulant therapy (i.e. acenocoumarol)
- •6\.severe liver dysfunction (Child\-Pughscore 10–15\)
- •7\.congestive heart failure
- •8\.cardiogenic shock
- •9\.left ventricular ejection fraction \< 35%
- •10\.bleeding diathesis
Outcomes
Primary Outcomes
Not specified
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