ACTIVE
Co-investigator in the study ACTIVE W+I and ACTIVE A+I (Atrial Fibrillation Clopidogrel Trial with Irbesartan for Prevention of Vascular Events). The ACTIVE W was a multicenter, randomized, double blind, trial on atrial fibrillation intended to demonstrate the noninferiority of dual antiplatelet therapy with aspirin and clopidogrel versus oral anticoagulation with vitamin K antagonists. The ACTIVE A aimed to demonstrate the superiority of dual antiplatelet therapy with aspirin and clopidogrel versus aspirin alone in patients with atrial fibrillation and contraindications to oral anticoagulation. In both trials the participants who were hypertensive could be additionally randomized to ACTIVE I comparing the administration of irbesartan (300 mg/day) versus placebo. Our center included 25 patients in the study, which were observed after 0, 1, 3, 6, 9, 12, 16, 18, 24, 30 and 36 months.
ClinicalTrials.gov Identifier: NCT00249873 e NCT00243178.
clinicaltrials.gov/NCT00249873
clinicaltrials.gov/NCT00243178
CRESCENDO
Co-investigator in the study CRESCENDO (Comprehensive Rimonabant Evaluation Study of Cardiovascular Endpoints and Outcomes) consisting of a multicenter, randomized, double blind, clinical trial including individuals with abdominal obesity and clinically established atherosclerotic disease or a combination of multiple risk factors for cardiovascular disease. It aimed to test the efficacy of rimonabant, an endocannabinoids receptor antagonist, in reducing morbidity and mortality from vascular events and its safety profile. Our center included 25 patients in the study, which were observed after 0, 1, 3, 6, 9, 12, 16, 18 and 24 months.
ClinicalTrials.gov Identifier: NCT00263042.
clinicaltrials.gov/NCT00263042
INSPIRE-ME/IAA
Co-investigator in the study INSPIRE-ME/IAA (International Study of Prediction of Intra- Abdominal Adiposity and Cardiometabolic Risk with its Relationships/Intra-Abdominal Adiposity). A prospective observational multicenter study about obesity. Patients underwent an initial clinical assessment and anthropometric examination complemented with abdominal CT quantification of intra-abdominal fat. After 12 and 24 months patients were clinically investigated. The aim of the study was to correlate the quantification of intra-abdominal fat and various anthropometric parameters with clinical prognosis. Our center included 20 patients.
CVEA489A2302
Co-investigator in the study CVEA489A2302, a multicenter, randomized, double-blind, trial in arterial hypertension grade II and III (ESC/ESH). It aimed to compare the efficacy and safety of triple combination valsartan/hydrochlorothiazide/amlodipine with the dual combination valsartan/hydrochlorothiazide, valsartan/amlodipine and hydrochlorothiazide/amlodipine. The duration of follow up in the study was 8 weeks preceded by a pre-randomization on placebo over 3 weeks with weekly visits. Our center included 4 patients in the pre-randomization, none of which had inclusion criteria at the end of this phase.
ClinicalTrials.gov Identifier: NCT00327587.
clinicaltrials.gov/NCT00327587
ExTRACT-TIMI-25
Co-investigator in the study EXTRACT-TIMI-25 (Thrombolysis enoxaparin and reperfusion for Acute Myocardial Infarction). A multicenter randomized trial in acute myocardial infarction with ST-segment elevation undergoing fibrinolysis. It aimed to compare the efficacy and safety of anticoagulation with enoxaparin versus unfractionated heparin. Our Center contributed with 3 patients who were observed at 0, 1, 6 and 12 months.
ClinicalTrials.gov Identifier: NCT00077792.
clinicaltrials.gov/NCT00077792
PLATO
Co-investigator in the study PLATO (A Study of Platelet Inhibition and Patient Outcomes for Adults with Acute Coronary Syndrome). A randomized, multicenter clinical trial, on anti-platelet aggregation in acute coronary syndromes. It aimed to compare the efficacy and safety of a new drug (AZD6140) with clopidogrel.
ClinicalTrials.gov Identifier: NCT00391872.