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

• ClinicalTrials.gov Identifier: NCT01593644
• Recruitment Status: Unknown
• First Posted: May 8, 2012
• Last Update Posted: September 7, 2012
• Sponsor: Adenobio N.V
• Information provided by (Responsible Party): Adenobio N.V

Tracking Information

• First Submitted Date: May 6, 2012
• First Posted Date: May 8, 2012
• Last Update Posted Date: September 7, 2012
• Study Start Date: June 2011
• Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 7, 2012)

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

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT01593644 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: May 7, 2012)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Phase II Study for the Diagnosis and Functional Assessment of CAD Using Transthoracic-Echodoppler
• 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
• Brief 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

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: Interventional
• Study Phase: Phase 2
• Study Design: Intervention Model: Single Group Assignment; Masking: Single (Participant)
• Condition: Ischemic Heart Disease

Intervention

Drug: adenosine + dipyridamole

adenosine / dipyridamole combination given intravenously as a slow bolus at low doses

Other Names:

• Adenosine : Krenosin® vials with 6 mg of adenosine in 2 ml fluid
• concentration of 3 mg /ml)
• Dipyridamole : injectable Persantine® - vials of 10 mg/2 ml

Study Arms

Experimental: adenosine + dypiridamole

Intervention: Drug: adenosine + dipyridamole

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: September 6, 2012): 75
• Original Estimated Enrollment (submitted: May 7, 2012): 35
• Study Completion Date: Not Provided
• Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01593644
• Other Study ID Numbers: ADEN-Ph2-2011-1
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Adenobio N.V
• Study Sponsor: Adenobio N.V
• Collaborators: Not Provided

Investigators

• Principal Investigator: Patrick Meimoun, PhD; Centre Hospitalier de Compiègne

• PRS Account: Adenobio N.V
• Verification Date: September 2012