Ischemic Heart DiseasePhase 2NCT01593644
Phase II Study for the Diagnosis and Functional Assessment of CAD Using Transthoracic-Echodoppler
A Phase 2 study testing adenosine + dipyridamole in people with Ischemic Heart Disease, run by Adenobio N.V at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- adenosine + dipyridamole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2011to Mar 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier de Compiègne
Compiègne, 60321
Patrick MEIMOUN, +33 3 44 23 62 39, p.meimoun@ch-compiegne.fr
Patrick MEIMOUN, PhD
About this study
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
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
Read the 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.
- Conditions
- Ischemic Heart Disease
- Being tested
- adenosine + dipyridamole
- Keywords
- Dipyridamole/adenosine combination given intravenously, slow bolus and low doses, coronary flow reserve assessment, transthoracic echodoppler, Patients, stable
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adenosine + dipyridamoleDrug
Also called 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
adenosine / dipyridamole combination given intravenously as a slow bolus at low doses
| Study group | Role | What they receive |
|---|---|---|
| adenosine + dypiridamole | Experimental | Not described Receives: Drug: adenosine + dipyridamole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diastolic mean and peak coronary blood velocities
hemodynamic efficacy, with maintenance of the optimal hyperemic coronary effect for at least 45 to 60 seconds after the end of the injection
Measured: 2 minutes
Secondary outcomes (1)
Incidence rate and severity of adverse events, in particular, chest pain, dyspnoea, hypotension, bradycardia, AV blocks, arrhythmia.
Incidence rate of A1 adverse events and of the severity of A2 and A1 clinical symptoms
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startJun 2011
- Primary completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adenobio N.V
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Meimoun, PhD, Principal investigator, Centre Hospitalier Intercommunal de Compiègne-Noyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01593644
- Sponsor's protocol ID
- ADEN-Ph2-2011-1
- Status last verified
- Sep 2012
- First submitted
- 6 May 2012
- Last updated
- 7 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01593644
- Acronym / sponsor ID
- ADEN-Ph2-2011-1
- Conditions
- Ischemic Heart Disease
- Keywords
- Dipyridamole/adenosine combination given intravenously, slow bolus and low doses, coronary flow reserve assessment, transthoracic echodoppler, Patients, stable
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Adenobio N.VUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Mar 2013 (estimated)
- First posted
- 8 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adenosine + dypiridamole | Experimental | Drug: adenosine + dipyridamole |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adenosine + dipyridamoleAlso: 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 mladenosine / dipyridamole combination given intravenously as a slow bolus at low doses | Drug | adenosine + dypiridamole |
Primary outcome
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
1 secondary outcome
Incidence rate and severity of adverse events, in particular, chest pain, dyspnoea, hypotension, bradycardia, AV blocks, arrhythmia.
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Meimoun, PhD principal investigator
Centre Hospitalier Intercommunal de Compiègne-Noyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing adenosine + dipyridamole in people with Ischemic Heart Disease, run by Adenobio N.V at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe GORNY, PhD,MD (+33 616 764 464, pg@adenobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diastolic mean and peak coronary blood velocities (time frame: 2 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2012.