- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01593644
Phase II Study for the Diagnosis and Functional Assessment of CAD Using Transthoracic-Echodoppler
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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 Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Philippe GORNY, PhD,MD
- Phone Number: +33 616 764 464
- Email: pg@adenobio.com
Study Locations
-
-
-
Compiègne, France, 60321
- Recruiting
- Centre Hospitalier de Compiegne
-
Contact:
- Patrick MEIMOUN
- Phone Number: +33 3 44 23 62 39
- Email: p.meimoun@ch-compiegne.fr
-
Principal Investigator:
- Patrick MEIMOUN, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Man or post-menopausal woman or with an oral contraceptive treatment , > 18 years
- Provided written consent by patient with good understanding of the study objectives as explained by the investigator during the initial visit
- Patient with a potential or known Coronary Artery Disease
- Patient for whom transthoracic ultrasonography for coronary reserve assessment is deemed useful
Exclusion Criteria:
- Subjects under 18, pregnant or breast-feeding woman, psychotic patients or subjects placed under administrative and legal authority
- Patients judged by investigator as not able to understand the study objectives
- Patients with a medical history, in particular a heart disease history (eg AV block) judged as non eligible by investigator
- Patients whose medical treatment contra- indicates their inclusion in the study (eg chronic use of oral dipyridamole, pentoxifylline), if not stopped at least 72 hours before the study test
- Patients with symptomatic bradycardia (<40 beat/min) or with systemic hypotension (SBP > 90 mmHg
- Patients with a 2nd and 3rd degree AV block, a sick sinus syndrome, but not those with artificial pacemaker
- Patients with prolonged QT (QTc>480 ms)
- Patients with oral dipyridamole who did not stopped their medication 48hrs before the study test
- Patients who received theophylline within 5 days before study test
- Consumption of coffee, cola, tea, chocolate within 12 hrs before study test
- Patients with a history of unstable Asthma or Chronic Obstructive Pulmonary Disease with bronchoconstriction
- Patients with unstable angina pectoris or uncontrolled severe heart failure
- Patients with a recent myocardial infarction history (<7 days), or stroke episode (< 1 month)
- Patients with known TC stenosis and not yet revascularized, uncontrolled hypovolemia, known and unfixed valvular stenosis, left-right shunt, pericarditis, sympathetic nervous system dysfunction, carotid stenosis , any significant cerebrovascular insufficiency
- Patients with known allergy to adenosine or dipyridamole
Study Plan
How is the study designed?
Design Details
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: adenosine + dypiridamole
|
adenosine / dipyridamole combination given intravenously as a slow bolus at low doses
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
2 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Patrick Meimoun, PhD, Centre Hospitalier de Compiegne
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Heart Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Vasodilator Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Platelet Aggregation Inhibitors
- Purinergic Agents
- Phosphodiesterase Inhibitors
- Purinergic P1 Receptor Agonists
- Purinergic Agonists
- Dipyridamole
- Adenosine
Other Study ID Numbers
- ADEN-Ph2-2011-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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