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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Adenobio N.V.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Adenobio N.V
ClinicalTrials.gov Identifier:
NCT01593644
First received: May 6, 2012
Last updated: September 6, 2012
Last verified: September 2012
  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

Resource links provided by NLM:


Further study details as provided by Adenobio N.V:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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:
  • 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

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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01593644

Contacts
Contact: Philippe GORNY, PhD,MD +33 616 764 464 pg@adenobio.com

Locations
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         
Sponsors and Collaborators
Adenobio N.V
Investigators
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
Heart Diseases
Ischemia
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Disease
Pathologic Processes
Vascular Diseases
Adenosine
Dipyridamole
Analgesics
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Enzyme Inhibitors
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Sensory System Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 27, 2014