Discovering beneficial properties of ticagrelor in acute myocardial infarction

• Register: EUCTR
• Last refreshed on: 25 November 2019
• Main ID: EUCTR2014-005363-33-NL
• Date of registration: 16/04/2015
• Prospective Registration: Yes
• Primary sponsor: VU university medical center
• Public title: Discovering beneficial properties of ticagrelor in acute myocardial infarction
• Scientific title: Reducing Micro Vascular dysfunction In revascularized STEMI patients by off-target properties of ticagrelor - REDUCE-MVI
• Date of first enrolment: 16/04/2015
• Target sample size: 110
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-005363-33
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Netherlands, Spain

Contacts

• Name: M. van Leeuwen
• Affiliation: VU university medical center

• Name: M. van Leeuwen
• Affiliation: VU university medical center

Key inclusion & exclusion 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
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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

ST elevation myocardial infarction (STEMI)

Intervention(s)

Trade Name: Brilique 90 mg film coated tablets
Product Name: Ticagrelor / brilique
Pharmaceutical Form: Coated tablet

Trade Name: Prasugrel / efient
Product Name: efient
Product Code: EU/1/08/503/015
Pharmaceutical Form: Tablet

Primary Outcome(s)

Main Objective: To determine if ticagrelor at treatment steady state (30 days maintenance therapy) will be associated to an improved microvascular function as compared to prasugrel in revascularized STEMI patients.

Primary end point(s): Index of microcirculatory resistance (IMR) at treatment steady state (1 month after primary PCI) in the infarct-related vessel, assessed with a pressure wire (Certus, St Jude Medical, St Paul,MN, USA).

Timepoint(s) of evaluation of this end point: 1 month after primary PCI

Secondary Objective: Not applicable

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: - RHI: Baseline (1 day after primary PCI) and follow-up (1 month, 1 year and 1.5 year)
- IMR: Baseline (directly after primary PCI) and follow-up ( 1 month)
- Endothelial function blood samples: Baseline (directly after primary PCI) and follow-up (3 days, 1 month, 1 year and 1.5 year)
- Palmar Collateral Flow Index (PCFI) at 1.5-year follow-up

Secondary end point(s): - The reactive hyperemia index (RHI) at treatment steady state (1 month after primary PCI), assessed
with endopath system (Endopath; Itamar Medical Ltd., Cesarea, Israel).
- The delta IMR between baseline and follow-up in both the infarct-related vessel and non-infarct related vessel.
- The delta RHI between baseline and follow-up
- The level of endothelial function as measured by several parameters (endothelin-1, NO synthase, e-NOS and dimethylarginine ) at follow-up

Secondary ID(s)

ESR-14-10048

Source(s) of Monetary Support

VU university medical center

Ethics review

Status: Approved
Approval date:
Contact: