A PHASE 3B, OPEN-LABEL, PARALLEL GROUP, RANDOMIZED, MULTICENTER STUDY TO ASSESS REGADENOSON ADMINISTRATION FOLLOWING AN INADEQUATE EXERCISE STRESS TEST AS COMPARED TO REGADENOSON ALONE FOR MYOCARDIAL PERFUSION IMAGING (MPI) USING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY (SPECT)
- Registration Number
- PER-071-12
- Lead Sponsor
- Astellas Pharma Global Development, Inc. (APGD),
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Not specified
- Target Recruitment
- 2
1. INSTITUCIONAL REVIEW BOARD (IRB)-/INDEPENDENT ETHICS COMMITTEE (IEC)-APPROVED WRITTEN INFORMED CONSENT AND PRIVACY LANGUAGE AS PER NATIONAL REGULATIONS (E.G., HIPAA AUTORIZATION FOR U.S. SITES) MUST BE OBTAINED FROM THE SUBJECT OR LEGALLY AUTHORIZED REPRESENTATIVE PRIOR TO ANY STUDY-RELATED PROCEDURES (INCLUDING WITHDRAWAL OF PROHIBITED MEDICATION, IF APPLICABLE).
2. MALE AND FEMALE SUBJECT ≥ 18 YEARS OF AGE REFERRED FOR AN EXERCISE OR PHARMACOLOGIC STRESS TEST SPECT MPI PROCEDURE FOR THE EVALUATION OF CORONARY ARTERY DISEASE ARE ELIGIBLE FOR STUDY PARTICIPATION. SUBJECTS REFERRED FOR PHARMACOLOGIC STRESS SHOULD HAVE A REASONABLE POTENTIAL OF ATTEMPTING EXERCISE STRESS IN THE OPINION OF THE INVESTIGATOR. SUBJECT MUST HAVE ONE OF THE FOLLOWING:
A. PAST ISCHEMIA ON ANY PRIOR IMAGING STRESS TEST WITHOUT INVASIVE INTERVENTION ON THE ARTERY SUBTENDING THIS TERRITORY.
B. SUBJECT WITH KNOWN CAD WHO HAVE SYMPTOMS SIMILAR TO PREVIOUS ISCHEMIC SYMPTOMS, OR RECENT ONSET OF SYMPTOMS OR RECENTLY WORSENED SYMPTOMS SUGGESTIVE OF ISCHEMIA.
C. DIAMOND FORRESTER ESTIMATED PRETEST PROBABILITY OF CAD OF ≥ 50 % (SEE APPENDIX 9).
1. SUBJECT IS CONCURRENTLY PARTICIPATING IN ANOTHER DRUG STUDY OR HAS RECEIVED AN INVESTIGATIONAL DRUG WITHIN 30 DAYS PRIOR TO SCREENING.
2. SUBJECT HAS A CLINICALLY SIGNIFICANT ILLNESS, MEDICAL CONDITION, OR LABORATORY ABNORMALITY, ACTIVE OR HISTORIC, WHICH IN THE INVESTIGATOR’S OPINION WOULD PRECLUDE PARTICIPATION IN THE STUDY.
3. DURING THE PERFORMANCE OF EXERCISE, IN THE INVESTIGATOR’S JUDGMENT, THE SUBJECT WILL ACHIEVE ≥ 85 % MPHR AND 5 METS OR IN THE INVESTIGATOR’S JUDGMENT, SIGNIFICANT ISCHEMIA IS PRESENT AND PHARMACOLOGICAL STRESS IS NOT REQUIRED.
4. FEMALE SUBJECT WHO IS PREGNANT OR LACTATING.
5. SUBJECT IS ON DIALYSIS FOR END STAGE RENAL DISEASE OR HAS A HISTORY OF GER < 15 ML/MIN(CALCULATED USING MDRD[MODIFICATION OF DIET IN RENAL DISEASE] FORMULA , SEE APPENDIX 11).
6. SUBJECT HAS A HISTORY OF CORONARY REVASCULARIZATION BY EITHER PCI OR CABG WITHIN 1 MONTH PRIOR TO THE REST MPI.
7. SUBJECT HAS A PACEMAKER OR AN IMPLANTABLE CARDIOVETER DEFIBRILLATOR (ICD).
8. SUBJECT IS REFERRED FOR EXERCISE MPI AND HAS A DUKE ACTIVITY STATUS INDEX SCORE (DASI) OF > 4.7 METS UNLESS CURRENTLY TAKING BETA BLOCKERS OR RATE SLOWING CALCIUM CHANNELBLOCKERS, OR HAS KNOWN CHRONOTROPIC INCOMPETENCE (SEE APPENDIX 10).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method