Reducing Micro Vascular Dysfunction in Acute Myocardial Infarction by Ticagrelor

Myocardial Infarction Clinical Trial

— REDUCE-MVI  

Official title:

Reducing Micro Vascular Dysfunction In Revascularized ST-elevation Myocardial Infarction Patients by Off-target Properties of Ticagrelor

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02422888
• Other study ID #: ESR-14-10048
• Secondary ID: 2014-005363-33
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: May 2015
• Est. completion date: October 2019

Study information

• Verified date: April 2018
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: October 2019
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Drug:
• Ticagrelor
After a standard loading dose of 180 mg ticagrelor in the ambulance (before primary PCI), patients will receive a maintenance dose of ticagrelor 90 mg twice a day for 1 year.
• Prasugrel
After a standard loading dose of 180 mg ticagrelor in the ambulance (before primary PCI), patients will receive a single loading dose of prasugrel 60 mg (1 day after standard loading dose ticagrelor),followed by a maintenance dose of prasugrel 10 mg once a day for 1 year.

Locations

Country	Name	City	State
Netherlands	VU University Medical Center	Amsterdam	Noord-Holland

Sponsors (5)

Lead Sponsor	Collaborator
VU University Medical Center	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Erasmus Medical Center, Hospital San Carlos, Madrid, University Medical Center Nijmegen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Index of microcirculatory resistance (IMR)	measured in the infarct-related artery	1 month after primary PCI
Secondary	Delta Index of microcirculatory resistance (IMR)	measured in the infarct-related artery and non-infarct related artery	Baseline vs. 1 month follow-up
Secondary	The reactive hyperemia index (RHI)		1 month and 1 year after primary PCI
Secondary	Myocardial salvage	measured with MRI	1 month after primary PCI
Secondary	Left ventricular ejection fraction (LVEF) recovery	measured with MRI	1 month after primary PCI
Secondary	Microvascular obstruction	measured with MRI	3 days after primary PCI
Secondary	Asymmetric Dimethylarginine (ADMA) levels	Blood measurements	1 month after primary PCI
Secondary	Intra-myocardial haemorrhage	measured with MRI	3 days after primary PCI