Reducing Micro Vascular Dysfunction in Acute Myocardial Infarction by Ticagrelor (REDUCE-MVI)

Amsterdam UMC, location VUmc

Status and phase: Unknown; Phase 4

Conditions: Myocardial Infarction

Treatments: Drug: Prasugrel; Drug: Ticagrelor

Study type: Interventional

Funder types: Other

Identifiers

NCT02422888

ESR-14-10048

2014-005363-33 (EudraCT Number)

Details and patient eligibility

About

The current trial will compare the protective effect of ticagrelor and prasugrel on microvascular dysfunction in patients with revascularized ST elevation myocardial infarction.

Full description

Coronary microvascular dysfunction is highly prevalent in revascularized ST-elevation myocardial infarction and has important prognostic implications. Current data suggest that ticagrelor might be superior to prasugrel in the reduction of coronary microvasculature dysfunction. Thus, we have designed a clinical trial that will compare microvascular function in revascularized ST-elevation myocardial infarction patients at treatment steady state with ticagrelor or prasugrel. Coronary microvascular dysfunction will be assessed with the index of microcirculatory resistance after primary percutaneous coronary intervention and at 1 month follow-up in the infarct-related vessel and non-infarct related vessel.

Enrollment: 110 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Provision of informed consent
2. Patients presenting with ST-elevation myocardial infarction <12 hours after symptom onset
3. Successful percutaneous coronary intervention of the infarct-related vessel with a modern drug-eluting stent
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-Pugh score 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 drug-eluting stent
29. Inability to obtain informed consent
30. Coronary artery bypass grafting in medical history

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

110 participants in 2 patient groups

Ticagrelor

Experimental group

Description:

Ticagrelor 90 mg twice a day, tablet Duration: 1 year after PCI

Treatment:

Drug: Ticagrelor

Prasugrel

Active Comparator group

Description:

Prasugrel 10 mg once a day, tablet Duration: 1 year after PCI

Treatment:

Drug: Prasugrel