Phase II Study for the Diagnosis and Functional Assessment of CAD Using Transthoracic-Echodoppler
Recruitment status was: Recruiting
|Study Design:||Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
|Official Title:||Phase 2, Monocentric, Single Blind Study, Comparing the Efficacy and Tolerance of a Dipyridamole/Adenosine Combination Given Intravenously, as a Slow Bolus and at Low Doses to Adenosine Alone for Coronary Flow Reserve Assessment (in Patients With Stable Ischemic Heart Disease) Using Transthoracic Echodoppler|
- Diastolic mean and peak coronary blood velocities [ Time Frame: 2 minutes ]hemodynamic efficacy, with maintenance of the optimal hyperemic coronary effect for at least 45 to 60 seconds after the end of the injection
- Incidence rate and severity of adverse events, in particular, chest pain, dyspnoea, hypotension, bradycardia, AV blocks, arrhythmia. [ Time Frame: 24 hours ]Incidence rate of A1 adverse events and of the severity of A2 and A1 clinical symptoms
|Study Start Date:||June 2011|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
|Experimental: adenosine + dypiridamole||
Drug: adenosine + dipyridamole
adenosine / dipyridamole combination given intravenously as a slow bolus at low doses
Phase 2, monocentric, single blind study, comparing the efficacy (primary endpoint) and the safety-tolerance profile (secondary endpoint) of a dipyridamole/adenosine combination given intravenously as a slow bolus and at low doses to adenosine alone given by the same route at its standard and recommended dose.
Expected results: Non inferiority of the combination compared to standard adenosine alone in terms of hemodynamic efficacy, with maintenance of the optimal hyperemic coronary effect for at least 45 to 60 seconds after the end of the injection -Significant reduction of the incidence rate of A1 adverse events and of the severity of A2 and A1 clinical symptoms.
Primary endpoint : diastolic mean and peak coronary blood velocities Secondary endpoint : incidence rate and severity of adverse events, in particular, chest pain, dyspnoea, hypotension, bradycardia, AV blocks, arrhythmia
Number of patients: 60-75 pts with 42-50 pts acceptable for statistical analysis
Day 1 (visit): Informed consent signature, Review of inclusion and exclusion criteria, Hemodynamic variables and EKG, Cardiac history, Significant other medical diseases, Risk factors, Concomitant treatment and substances consumed within 48 hours, Transthoracic ultrasonography, Adverse events report Day 2 (telephone contact): Adverse events report
Duration of the study: 15 months
Statistical Analysis: Statistical tests will include :a paired test analysis and comparison of the means (quantitative variables) -Possibly the Mac-Nemar test for the assessment of clinical adverse events during the study test with both products.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01593644
|Centre Hospitalier de Compiègne|
|Compiègne, France, 60321|
|Principal Investigator:||Patrick Meimoun, PhD||Centre Hospitalier de Compiègne|