CP-175 Descriptive analysis of active clinical trials in cardiology service

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Abstract

Background

Cardiovascular diseases are the leading cause of death in Europe making it necessary to promote research projects.

Purpose

To describe active cardiology clinical trials (CT) and the distribution of included patients. To analyse investigational drugs (ID).

Material and methods

This was a descriptive observational study in a tertiary hospital. Active cardiology CT were considered from January 2015 to October 2016. ID were classified into: new molecule, new indication and new scheme. Collected data were: number of CT and patients, medical conditions included, ID and phase, trial design, location of study and promoter.

Results

26 CT with a total of 336 patients, and a mean of 13.4 patients per CT (range 0–96) were studied. The number of CT/number of patients by medical condition was: chronic heart failure n=13/55 (50%/16.4%); acute coronary syndrome n=4/110 (15.4%/32.7%); cardiomyopathy n=2/6 (7.7%/1.8%); unstable angina n=1/32 (3.8%/9.5%); dyslipidaemia n=1/96 (3.8%/28.6%); atrial fibrillation n=1/21 (3.8%/6.25%); pulmonary hypertension n=1/3 (3.8%/0.9%); platelet reactivity after transcatheter aortic valve implantation n=1/11 (3.8%/3.3%); and patients with bicuspid aortic valve and venous thromboembolism n=1/1 (3.8%/0.3%). Regarding the ID, the distribution of CT/patient was: 12/211 new molecules (46.2%/68.8%), 12/90 new indications (46.2%/26.8%) and new schemes 2/35 (7.7%/10.4%). Depending on the phase, the number of CT/number of patients was: 6/47 phase II (23.1%/14%); 15/246 phase III (57.7%/73.2%); and 5/46 phase IV (19.2%/13.7%). A total of 25 CT (96.1%) were multicentre and controlled; 20 (76.9%) double blind; 16 (64%) with placebo; and six (23.1%) were open label. According to the study location, 21 (80.8%) were international. The industry promoted 22 CT (84.6%).

Conclusion

There has been a predominance of multicentre, randomised, phase III, double blind, placebo controlled CT. Most were international and promoted by industry. There was a high number of patients per cardiology CT, showing a predominance of those included in phase III and acute coronary syndrome. However, the largest number of trials was focused on chronic heart failure. No differences were shown for the number of CT studying new drugs or new indications, although more than two-thirds of patients were included in CT that were studying new drugs.

Conclusion

No conflict of interest

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