DalCor is set to increase enrolment in its ongoing dal-GenE trial, a Phase III clinical study of dalcetrapib, from 5000 to 6000 patients.
The development is based on better than expected enrolment results witnessed by dal-GenE, which has so far randomised a total of 4300 patients around five months ahead of enrolment projections.
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The randomised, placebo-controlled trial will enrol 6000 patients recently hospitalised with acute coronary syndrome (ACS).
Patients who have expressed the AA genotype at variant rs1967309 in the ADCY9 gene – as determined by an investigational companion diagnostic test developed by Roche Molecular Systems (RMS)- will also be included in the trial.
The trial’s primary endpoint is the time to first occurrence of any component of the composite of cardiovascular death, myocardial infarction (heart attack) and stroke.
It is currently being conducted in more than 700 sites in 33 countries worldwide.
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By GlobalDatadal-GenE executive committee chair Dr Jean-Claude Tardif said: “The success of the enrolment has provided the opportunity to reconsider initial assumptions to strengthen the trial design.
“As a result, the sample size of the dal-GenE study will be increased to 6000 patients while maintaining the originally projected recruitment timelines of year-end 2018.
“The prospect of precision medicine for cardiovascular health has been embraced by our colleagues around the world.”
With the expansion of patient number, DalCor also aims to increase the precision of the trial.
Dalcetrapib is a medicine designed to target cardiovascular diseases.
