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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44678

Enrollment

110

Registered

2017-06-14

Start date

2015-05-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart attack Myocardial infarction

Interventions

The study population will be randomized to a maintenance dose of ticagrelor or prasugrel.

microvascular function

myocardial infarction

Prasugrel

Ticagrelor

Eligibility

Age

18 Years to 64 Years

Inclusion 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%)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
microvascular function as determided by IMR in the infarct-related vessel at 30 days follow-up	—

Secondary

Measure	Time frame
1) microvascular function as determided the delta IMR in the infarct-related vessel (baseline vs. 1-month f-up). 2) microvascular function as determided the (delta) IMR in the non-infarct-related vessel 3) microvascular function as determided by the (delta) RHI as determined by EndoPat 4) microvascular function as determided by the (delta) level of biochemical markers	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)