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ADMINISTRATION OF TICAGRELOR IN PATIENTS WITH ST ELEVATION MYOCARDIAL INFARCTION TREATED WITH PHARMACOLOGICAL THROMBOLYSIS

A 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 CLOPIDOGREL IN PATIENTS WITH ST ELEVATION MYOCARDIAL INFARCTION TREATED WITH PHARMACOLOGICAL THROMBOLYSIS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-008-16
Enrollment
200
Registered
2016-08-16
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Ticagrelor 180mg as early as possible after the index event and not >24 h post event, followed by 90 mg BID . Clopidogrel 300mg as early as possible after the index event and not > 24h post event, fol

Sponsors

Associação do Sanatorio Sirio – Hospital do Coração,
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients with a diagnosis of acute coronary syndrome with ST 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. Both male and female, aged &#8805; 18 years and < 75 years Agreement to provide written informed consent

Exclusion criteria

Exclusion criteria: • any contraindication against the use of clopidogrel or ticagrelor (eg, hypersensitivity, moderate or severe liver disease, active bleeding or recent bleeding history, history of intracranial hemorrhage) • need for oral anticoagulation therapy, or aspirin doses per day more than 100mg/day. • 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 bradyarrithmias • 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 • Current use of Ticagrelor • 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

Countries

Argentina, Australia, Brazil, Canada, China, Colombia, Mexico, Peru, Russian Federation

Contacts

Public ContactGerman Javier Malaga

PREVI-MED S.A.C

gmalaga01@gmail.com992768300

Outcome results

None listed

Source: REPEC (via WHO ICTRP)