Reducing Micro Vascular dysfunction In revascularized STEMI patients by off-target properties of ticagrelor

Completed

• Conditions: Heart attack; Myocardial infarction; 10011082

• Registration Number: NL-OMON44678
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 110

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%)

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
11. age >= 75 or < 18
12. body weight < 60 kg
13. gout
14. coagulation disorders
15. severe pulmonary disease
16. pregnancy and breast feeding
17. limited life expectancy
18. platelet count < 100 000/mm3
19. history of drug addiction or alcohol abuse in the past 2 years
20. need for chronic nonsteroidal anti-inflammatory drug
21. creatinine clearance <30 mL/min or dialysis
22. chronic total occlusion (CTO)
23. Left main disease
24. allergy or contra-indication for ticagrelor or prasugrel
25. Contra-indication for adenosine
26. Patients unable to be followed on-site
27. Unable to undergo or contra-indications for MRI
28. Contra-indication for DES
29. Inability to obtain informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>microvascular function as determided by IMR in the infarct-related vessel at 30<br /><br>days follow-up</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) microvascular function as determided the delta IMR in the infarct-related<br /><br>vessel (baseline vs. 1-month f-up).<br /><br>2) microvascular function as determided the (delta) IMR in the<br /><br>non-infarct-related vessel<br /><br>3) microvascular function as determided by the (delta) RHI as determined by<br /><br>EndoPat<br /><br>4) microvascular function as determided by the (delta) level of biochemical<br /><br>markers</p><br>