Status:
COMPLETED
Ticagrelor in Patients With ST Elevation Myocardial Infarction Treated With Pharmacological Thrombolysis
Lead Sponsor:
Hospital do Coracao
Conditions:
Acute ST Segment Elevation Myocardial Infarction
Thrombolysis in Myocardial Infarction Flow
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Administration of Ticagrelor in patients with ST elevation myocardial infarction treated with pharmacological thrombolysis
Detailed Description
Phase III, Randomized, International, Multicenter, Open label, with Blinded Adjudication of Outcomes, Non-Inferiority Clinical Trial to Explore the Safety and Efficacy of Ticagrelor Compared with Clop...
Eligibility Criteria
Inclusion
- Patients of both sexes aged ≥ 18 years and \< 75 years with ACS with ST segment elevation with onset during the previous 24 hours, documented by cardiac ischemic symptoms due to atherosclerosis of \> 10 minutes duration at rest, treated with pharmacological thrombolysis
- Fibrinolytic therapy should be given to patients with STEMI and onset of ischemic symptoms within the previous 12 hours
- Patients with acute coronary syndrome with ST segment elevation will be included provided they present ST segment elevation at the J point in two contiguous leads in electrocardiogram with cut-points: \> 0.1mV in all leads other than leads V2-V3, where the following cut points apply: \> 0.2 mV in men \> 40 years; \> 0.25 mV in men \< 40 years, or \>0.15 mV in women and at least 1 of the following criteria:
- Angina-like chest pain or ischemic equivalent chest pain;
- Abnormalities above the reference value for markers of myocardial necrosis (troponin and CK-MB).
- The patient must be able to give informed consent in accordance with ICH GCP guidelines and local legislation and/or regulations.
Exclusion
- Any contraindication against the use of clopidogrel (eg, hypersensitivity, moderate or severe liver disease, active bleeding or bleeding history, history of intracranial hemorrhage)
- Need for oral anticoagulation therapy,
- Concomitant oral or IV therapy with strong CYP3A inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, grapefruit juice N1 L/d), CYP3A substrates with narrow therapeutic indices (cyclosporine, quinidine), or strong CYP3Ainducers (rifampin/rifampicin, phenytoin, carbamazepine)
- Increased risk of bradycardia events
- Dialysis required
- Known clinically important thrombocytopenia
- Known clinically important anemia
- Any other condition that may put the patient at risk or influence study results in the investigators' opinion (eg, cardiogenic shock, severe hemodynamic instability, active cancer)
- Participant in another investigational drug or device study within 30 d
- Pregnancy or lactation
- Any condition that increases the risk for noncompliance or being lost to follow-up
- Involvement in the planning or conduct of the study
- Previous enrollment or randomization in this study
- Contraindications to fibrinolytic therapy including: 15
- Any prior intracranial hemorrhage
- Known structural cerebral vascular lesion (eg, Arterial Venous Malformation - AVM)
- Known malignant intracranial neoplasm (primary or metastatic)
- Ischemic stroke within 3 months
- Suspected aortic dissection
- Active bleeding or bleeding diathesis (excluding menses)
- Significant closed head trauma or facial trauma within 3 months
Key Trial Info
Start Date :
August 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2019
Estimated Enrollment :
3799 Patients enrolled
Trial Details
Trial ID
NCT02298088
Start Date
August 1 2015
End Date
January 1 2019
Last Update
February 15 2019
Active Locations (153)
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1
Hospital Interzonal General de Agudos Dr, José Penna
Bahía Blanca, Argentina
2
Hospital Alvarez
Buenos Aires, Argentina
3
Hospital Español de La Plata
La Plata, Argentina
4
Sanatorio Modelo de Quilmes
Quilmes, Argentina