A Phase III, Randomized, Double-Blind Study of Intravenous CVT 3146 vs. Adenoscan® in Patients Undergoing Stress Myocardial Perfusion Imaging - CVT 5131
- Conditions
- Myocardial Ischaemia (diagnosis of )MedDRA version: 7.1 Level: LLT Classification code 10028601
- Registration Number
- EUCTR2004-004976-35-GB
- Lead Sponsor
- CV Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 1070
Inclusion Criteria:
•Males or females > or = 18 years of age
•Referred for a clinically indicated pharmacological stress SPECT MPI
•Adequate IV access in both arms
•Willing to comply with the requirements of the protocol
•Provided written Informed Consent to participate in the study approved by an appropriately constituted Institutional Review Board / Independent Ethics Committee (IRB/IEC)
•Provided HIPAA authorization (US residents only)
After the initial adenosine scan, patients must continue to meet all the inclusion and exclusion criteria.
The following additional qualifying criteria must be met in order to be randomized to receive either CVT 3146 or adenosine for SPECT stress images.
•Adenosine images must be of good quality and have been acquired at least 24 hours and no more than 30 days before the subsequent randomized scan
•Initial adenosine scan infusion must be at least 5 ½ minutes at 140 mcg/kg/min ±10 mcg/kg/min.
•Stable medication regimen (i.e., no changes in medications that would be likely to alter the rate pressure product) must be maintained during the interval between the initial and second study
These medications include: beta blockers, calcium channel blockers, long-acting nitrates, ACE inhibitors, etc. These medications can be continued the day before each scan, but should preferentially be withheld the morning of the scans. If the withholding of these medications is contra-indicated, the medications may be continued on the day of the clinically indicated scan, provided that the same dosing and frequency regimen is then applied for the randomized scan, and also provided that the patient is administered both stress agents at approximately the same time of day (within one hour). Sublingual nitroglycerin is not allowed within 2 hours of either the initial or randomized study.
•Stable clinical condition with no meaningful change in signs or symptoms
•Once randomization has been closed to patients with 0-1 reversible segments, the initial scan must have at least 2 segments showing reversible defects
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
•History of coronary revascularization (PTCA, CABG or TMR (transmyocardial revascularization)) within 6 months prior to enrollment
•Prior cardiac transplantation
•Documented history of acute myocardial infarction or unstable angina within 3 months prior to enrollment
•Known history of hypertrophic cardiomyopathy with resting gradient
•History of greater than first degree AV Block, except for patients with a functioning artificial pacemaker
•History of acute myocarditis or pericarditis
•History of sick sinus syndrome, except for patients with a functioning artificial pacemaker
•History of severe aortic stenosis
•History of serious uncontrolled ventricular arrhythmia (any life-threatening ventricular arrhythmia, e.g., ventricular arrhythmia with hemodynamic compromise within the last 3 weeks and unresponsive to anti-arrhythmic medication therapy, or without automatic implantable cardiac defibrillator (AICD) backup, etc.)
•History of known or suspected bronchoconstrictive and bronchospastic lung disease (e.g., asthma, wheezing noted on physical exam or history of wheezing requiring a bronchodilator or corticosteroids)
•Known susceptibility to symptomatic hypotensive reactions (e.g., hypovolemia causing symptomatic hypotension)
•Known condition of symptomatic bradycardia
•Uncontrolled hypertension (> 200/120 mmHg) within 30 days
•Currently on theophylline / aminophylline
•Unable to discontinue dipyridamole for a period of 30 hours prior to each scan
•Known allergy to theophylline / aminophylline
•Sublingual nitroglycerin within 2 hours of receiving pharmacological stress agent
•Known hypersensitivity to adenosine
•Pregnant or breast feeding, or (if pre-menopausal), not practicing acceptable method of birth control
•Consumption of methylxanthine-containing products such as caffeinated coffee, tea, and soft drinks (e.g., Coke, Pepsi, Mountain Dew), theophylline, cocoa and chocolate within 12 hours prior to receiving pharmacological stress agent
•Any condition which may, in the Investigator's opinion, preclude the safe use of adenosine in the patient
•History of any other conditions which in the judgment of the Investigator, are likely to hinder or confuse study conduct or to pose a safety concern to the patient
•Participation in another investigational drug study within 1 month prior to enrollment into this study
•Participation in a previous trial studying CVT 3146
After the initial adenosine scan, patients must continue to meet all the inclusion and exclusion criteria. Any patient who has experienced an event or condition described in the exclusion criteria (e.g., uncontrolled ventricular arrhythmia, myocardial infarction, or persistent or symptomatic hypotension) should be discontinued.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method