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Discovering beneficial properties of ticagrelor in acute myocardial infarctio

Phase 1
Conditions
ST elevation myocardial infarction (STEMI)
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Registration Number
EUCTR2014-005363-33-NL
Lead Sponsor
VU university medical center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
Not specified
Target Recruitment
110
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

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Timepoint(s) of evaluation of this end point: 1 month after primary PCI;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.;Secondary Objective: Not applicable;<br> 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).<br><br>
Secondary Outcome Measures
NameTimeMethod
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