Clinical cardiology
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Clinical cardiology · Oct 2014
Randomized Controlled Trial Multicenter StudyEfficacy and safety of alirocumab as add-on therapy in high-cardiovascular-risk patients with hypercholesterolemia not adequately controlled with atorvastatin (20 or 40 mg) or rosuvastatin (10 or 20 mg): design and rationale of the ODYSSEY OPTIONS Studies.
The phase 3 ODYSSEY OPTIONS studies (OPTIONS I, NCT01730040; OPTIONS II, NCT01730053) are multicenter, multinational, randomized, double-blind, active-comparator, 24-week studies evaluating the efficacy and safety of alirocumab, a fully human monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9, as add-on therapy in ∼ 650 high-cardiovascular (CV)-risk patients whose low-density lipoprotein cholesterol (LDL-C) levels are ≥100 mg/dL or ≥70 mg/dL according to the CV-risk category, high and very high CV risk, respectively, with atorvastatin (20-40 mg/d) or rosuvastatin (10-20 mg/d). Patients are randomized to receive alirocumab 75 mg via a single, subcutaneous, 1-mL injection by prefilled pen every 2 weeks (Q2W) as add-on therapy to atorvastatin (20-40 mg) or rosuvastatin (10-20 mg); or to receive ezetimibe 10 mg/d as add-on therapy to statin; or to receive statin up-titration; or to switch from atorvastatin to rosuvastatin (OPTIONS I only). ⋯ The studies may provide guidance to inform clinical decision-making when patients with CV risk require additional lipid-lowering therapy to further reduce LDL-C levels. The flexibility of the alirocumab dosing regimen allows for individualized therapy based on the degree of LDL-C reduction required to achieve the desired LDL-C level.
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Clinical cardiology · Jul 2014
Multicenter StudyFrom door-to-balloon time to contact-to-device time: predictors of achieving target times in patients with ST-elevation myocardial infarction.
The 2013 American College of Cardiology Foundation/American Heart Association ST-segment elevation myocardial infarction (STEMI) guidelines have shifted focus from door-to-balloon (D2B) time to the time from first medical contact to device activation (contact-to-device time [C2D] ). ⋯ In STEMI patients, PHT was associated with significantly reduced C2D and D2B times and was an independent predictor of achieving a target C2D time. As centers adapt to the new guidelines emphasizing C2D time, targeting a shorter D2B time (<50 minutes) is ideal to achieve a C2D time of <90 minutes.
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Clinical cardiology · Jun 2014
Randomized Controlled Trial Multicenter StudyChoice of vein-harvest technique for coronary artery bypass grafting: rationale and design of the REGROUP trial.
The Randomized Endo-vein Graft Prospective (REGROUP) trial (ClinicalTrials.gov NCT01850082) is a randomized, intent-to-treat, 2-arm, parallel-design, multicenter study funded by the Cooperative Studies Program (CSP No. 588) of the US Department of Veterans Affairs. Cardiac surgeons at 16 Veterans Affairs (VA) medical centers with technical expertise in performing both endoscopic vein harvesting (EVH) and open vein harvesting (OVH) were recruited as the REGROUP surgeon participants. Subjects requiring elective or urgent coronary artery bypass grafting using cardiopulmonary bypass with use of ≥1 saphenous vein graft will be screened for enrollment using pre-established inclusion/exclusion criteria. ⋯ Telephone follow-ups will occur at 3-month intervals after surgery until the participating sites are decommissioned after the trial's completion (approximately 4.5 years after the full study startup). To assess long-term outcomes, centralized follow-up of MACE for 2 additional years will be centrally performed using VA and non-VA clinical and administrative databases. The primary MACE outcome will be compared between the 2 arms, EVH and OVH, at the end of the trial duration.
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Clinical cardiology · May 2014
Multicenter Study Clinical Trial Observational StudyPatterns of long-term thienopyridine therapy and outcomes in patients with acute coronary syndrome treated with coronary stenting: Observations from the TIMI-38 Coronary Stent Registry.
The optimal duration of dual antiplatelet therapy (DAPT) after acute coronary syndrome (ACS) is not known. Factors influencing DAPT duration are not well described. ⋯ Patients stabilized for a year after ACS and stenting have low rates of ST relative to overall cardiovascular events. The decision to continue DAPT maybe associated with stent type (DES vs bare-metal stent) and region.
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Clinical cardiology · Mar 2014
Randomized Controlled Trial Multicenter StudyDesign and rationale of the GAUSS-2 study trial: a double-blind, ezetimibe-controlled phase 3 study of the efficacy and tolerability of evolocumab (AMG 145) in subjects with hypercholesterolemia who are intolerant of statin therapy.
Statins effectively lower low-density lipoprotein cholesterol (LDL-C), reducing cardiovascular morbidity and mortality. Most patients tolerate statins well, but approximately 10% to 20% experience side effects (primarily muscle-related) contributing to diminished compliance or discontinuation of statin therapy and subsequent increase in cardiovascular risk. Statin-intolerant patients require more effective therapies for lowering LDL-C. ⋯ The primary objective of the study is to assess the effects of evolocumab on percentage change from baseline in LDL-C. Secondary objectives include evaluation of safety and tolerability, comparison of the effects of evolocumab vs ezetimibe on absolute change from baseline in LDL-C, and percentage changes from baseline in other lipids. Recruitment of approximately 300 subjects was completed in August 2013.