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Ticagrelor in Patients With ST Elevation Myocardial Infarction Treated With Pharmacological Thrombolysis

Information source: Hospital do Coracao
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute ST Segment Elevation Myocardial Infarction; Thrombolysis in Myocardial Infarction Flow

Intervention: Ticagrelor 180 mg (Drug); Clopidogrel (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Hospital do Coracao

Official(s) and/or principal investigator(s):
Otavio Berwanger, MD,PhD, Study Chair, Affiliation: Hospital do Coracao
Helio P Guimaraes, MD,PhD, Study Chair, Affiliation: Hospital do Coracao
Leopoldo S Piegas, MD,PhD, Study Chair, Affiliation: Hospital do Coracao
Renato D Lopes, MD,PhD, Study Chair, Affiliation: Hospital do Coracao
Jose C Nicolau, MD,PhD, Study Chair, Affiliation: Hospital do Coracao

Overall contact:
Otavio Berwanger, MD,PhD, Phone: + 55 (11) 3053-6611, Ext: 8201, Email: oberwanger@hcor.com.br

Summary

Administration of TicagRElor in pAtients with ST elevation myocardial infarction treated with pharmacological Thrombolysis

Clinical Details

Official title: Phase III, Randomized, Multicenter, Open Label, Non-Inferiority Trial to Explore the Safety and Efficacy of Ticagrelor Compared With Clopidogrel in Patients With ST Elevation Myocardial Infarction Treated With Pharmacological Thrombolysis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Safety Outcome as a measure of Time to TIMI-defined first major bleeding

Secondary outcome:

Efficacy Outcome as a measure of major cardiovascular events

Safety Outcome as a measure of bleeding event

Detailed description: A Phase III, Randomized, 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 Acute Coronary Syndrome with ST Elevation Treated with

Pharmacological Thrombolysis - TREAT

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 Criteria:

- 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

Locations and Contacts

Otavio Berwanger, MD,PhD, Phone: + 55 (11) 3053-6611, Ext: 8201, Email: oberwanger@hcor.com.br

Hospital do Coracao, Sao Paulo 040005-000, Brazil; Not yet recruiting
Otavio Berwanger, MD,PhD, Phone: + 55 (11) 3053-6611, Ext: 8201, Email: oberwanger@hcor.com.br
Additional Information

Starting date: August 2015
Last updated: November 19, 2014

Page last updated: August 23, 2015

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