To determine if ticagrelor at treatment steady state will be associated to an improved microvascular function as compared to prasugrel in revascularized STEMI patients.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
microvascular function as determided by IMR in the infarct-related vessel at 30
days follow-up
Secondary outcome
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
Background summary
Coronary microvascular dysfunction is highly prevalent in revacularized STEMI
and has important prognostic implications.The current data suggest that
ticagrelor might be superior to prasugrel in the reduction of coronary
microvasculature dysfunction after revacularized STEMI. To date, no
head-to-head comparison data is available of ticagrelor and prasugrel in terms
of clinical outcome. Both oral P2Y12 receptor antagonist achieve a more rapid,
consistent and greater platelet inhibition than clopidogrel and received a
class 1 recommendation in the current guidelines.
Study objective
To determine if ticagrelor at treatment steady state will be associated to an
improved microvascular function as compared to prasugrel in revascularized
STEMI patients.
Study design
multicentre trial with a prospective, randomized, open-label, blinded-endpoint
(PROBE) study design.
Intervention
The study population will be randomized to a maintenance dose of ticagrelor or
prasugrel.
Study burden and risks
One extra visit to the outpatient clinic at 1-year follow-up with a venous
puncture (for blood collection), EndoPat meusurement and two questionannaires
(total time: 60 minutes)
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-005363-33-NL |
| CCMO | NL51985.029.15 |