This is a prospective randomized study, which investigates the coronary microvascular function as assessed by coronary angiography after administration of ticagrelor compared with clopidogrel in patients with myocardial infarction and ST segment elevation after thrombolysis.
- Conditions
- Patients with Myocardial Infarction with ST-segment elevation (STEMI) undergoing thrombolysisMedDRA version: 18.0 Level: PT Classification code 10000891 Term: Acute myocardial infarction System Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2014-004082-25-GR
- Lead Sponsor
- Hellenic Cardiovascular Research Society
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 358
1) Provision of informed consent prior to any study specific procedures.
2) Male and female subjects, 18-75 years of age (both inclusive).
3) STEMI eligible for thrombolysis
4) Inability to perform primary PCI, because of transport time in centers carrying out primary PCI lasting more than two hours
5) Ability of transportation in 3-24 hours after thrombolysis in order to perform coronary angiography and PCI. This period may be extended for reasons of extreme importance up to 72 hours at the latest.
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 215
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 143
1)Inability to give informed consent.
2)Pre-treatment with any P2Y12 inhibitor within the 7-day period prior to randomization.
3)Cardiogenic shock – Killip class 4.
4)Suspicion or evidence of mechanical complication, including mitral valve dysfunction, ventricular septal rupture, and rupture of the left ventricle.
5)Current use of warfarin or other anticoagulant drug.
6)Known multivessel coronary artery disease not suitable for revascularization. 7)Any contraindication to thrombolytic therapy -Central nervous system damage or neoplasms or atrioventricular malformation -Recent major trauma/surgery/head injury (within the preceding 3 weeks) -Gastrointestinal bleeding within the past month -Known bleeding disorder (excluding menses) -Aortic dissection -Non-compressible punctures in the past 24 hours (e.g. liver biopsy, lumbar puncture). 8)Other bleeding diathesis, or considered by Investigator to be at high risk for bleeding.
9)Any kind of stroke in the past year or haemorrhagic stroke ever.
10)Severe uncontrolled hypertension (>180/110 mmHg) prior to randomisation. 11)Prolonged or traumatic cardiopulmonary resuscitation (> 10 minutes) in the last 2 weeks.
12)Known thrombocytopenia defined as platelet count of <100,000/mm3.
13)Known anemia (hemoglobin [Hb] <10 gr/dL).
14)Subjects receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors that cannot be discontinued for the duration of the study.
15)Chronic dialysis or known chronic renal failure (glomerular filtration rate (GFR)<30 ml/min/1.73m2).
16)Known moderate or severe hepatic impairment.
17)Severe uncontrolled chronic obstructive pulmonary disease.
18)Concomitant use of potent Cytochrome P450 3A4 (CYP3A4) inhibitors (atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole, grapefruit juice over 1 litre daily), CYP3A substrates with narrow therapeutic indices (cyclosporine, quinidine), or inducers (carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampin, and rifapentine).
19)Concomitant use of drugs that are metabolized through CYP2C19 (omeprazole and esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, ciprofloxacin, cimetidine, carbamazepine, oxcarbazepine and chloramphenicol).
20)Increased risk of bradycardic events (e.g. known sick sinus syndrome or third degree AV block or previous documented syncope suspected to be due to bradycardia unless treated with a pacemaker).
21)Any known contraindication to clopidogrel, ASA, or ticagrelor.
22)Current pregnancy, active lactation or parturition (childbirth) within the previous 30 days; women of childbearing potential must have a negative urine pregnancy test, or use a medically accepted method of birth control.
23)Treatment with other investigational agents (including placebo) or devices within 30 days prior to randomization or planned use of investigational agents or devices prior to the completion of study participation.
24)Any non-cardiac condition with life expectancy less
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: To demonstrate that coronary microvascular function as assessed with the TIMI frame counting method is improved after ticagrelor administration compared to clopidogrel administration in eligible STEMI subjects undergoing thrombolysis. <br> <br> ;Primary end point(s): The difference in Post PCI CTFC between the ticagelor and clopidogrel treatment arms. ;Timepoint(s) of evaluation of this end point: At the end of the study;<br> Secondary Objective: -To demonstrate that coronary microvascular function, as assessed with other angiographic outcomes, is improved after ticagrelor administration compared to clopidogrel administration in eligible STEMI subjects undergoing thrombolysis. <br> -To demonstrate that ticagrelor is associated with greater myocardial recovery than clopidogrel, as assessed by echocardiographic indexes, in eligible STEMI subjects undergoing thrombolysis. <br>
- Secondary Outcome Measures
Name Time Method