Ignite Creation Date:
2024-05-06 @ 12:31 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01593644
Status:
UNKNOWN
Last Update Posted:
2012-09-07
First Post:
2012-05-06
Brief Title:
Phase II Study for the Diagnosis and Functional Assessment of CAD Using Transthoracic-Echodoppler
Sponsor:
Adenobio NV
Organization:
Adenobio NV
Study Overview
Official Title:
Phase 2 Monocentric Single Blind Study Comparing the Efficacy and Tolerance of a DipyridamoleAdenosine 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
Status:
UNKNOWN
Status Verified Date:
2012-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy and tolerance of a dipyridamoleadenosine 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 dipyridamoleadenosine 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None