Phase II Study for the Diagnosis and Functional Assessment of CAD Using Transthoracic-Echodoppler
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Ischemic Heart Disease |
Drug: adenosine + dipyridamole |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Incidence rate of A1 adverse events and of the severity of A2 and A1 clinical symptoms
| Estimated Enrollment: | 75 |
| Study Start Date: | June 2011 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: adenosine + dypiridamole |
Drug: adenosine + dipyridamole
adenosine / dipyridamole combination given intravenously as a slow bolus at low doses
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Philippe GORNY, PhD,MD | +33 616 764 464 | pg@adenobio.com |
| France | |
| Centre Hospitalier de Compiègne | Recruiting |
| Compiègne, France, 60321 | |
| Contact: Patrick MEIMOUN +33 3 44 23 62 39 p.meimoun@ch-compiegne.fr | |
| Principal Investigator: Patrick MEIMOUN, PhD | |
| Principal Investigator: | Patrick Meimoun, PhD | Centre Hospitalier de Compiègne |
More Information
No publications provided
| Responsible Party: | Adenobio N.V |
| ClinicalTrials.gov Identifier: | NCT01593644 History of Changes |
| Other Study ID Numbers: | ADEN-Ph2-2011-1 |
| Study First Received: | May 6, 2012 |
| Last Updated: | September 6, 2012 |
| Health Authority: | France:ANSM formely called Afssaps - French Health Products Safety Agency |
Keywords provided by Adenobio N.V:
|
Dipyridamole/adenosine combination given intravenously slow bolus and low doses coronary flow reserve assessment |
transthoracic echodoppler Patients stable |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Heart Diseases Ischemia Coronary Disease Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Pathologic Processes Adenosine Dipyridamole Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anti-Arrhythmia Agents Cardiovascular Agents Vasodilator Agents Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Hematologic Agents |
ClinicalTrials.gov processed this record on May 22, 2013