Phase II Study for the Diagnosis and Functional Assessment of CAD Using Transthoracic-Echodoppler

Ischemic Heart Disease Clinical Trial

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

Status Recruiting

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and tolerance of a dipyridamole/adenosine combination given intravenously, as a slow bolus and at low doses to adenosine alone (given at its recommended dosage adjusted to patients' weight) for coronary flow reserve assessment (in 60-75 patients with stable ischemic heart disease) using transthoracic echodoppler

Clinical Trial Description

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

Operating procedures:

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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

• NCT number: NCT01593644
• Study type: Interventional
• Source: Adenobio N.V
• Contact: Philippe GORNY, PhD,MD
• Phone: +33 616 764 464
• Email: pg@adenobio.com
• Status: Recruiting
• Phase: Phase 2
• Start date: June 2011