Ad5FGF-4 In Patients With Refractory Angina Due to Myocardial Ischemia (AFFIRM)
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|ClinicalTrials.gov Identifier: NCT02928094|
Recruitment Status : Not yet recruiting
First Posted : October 10, 2016
Last Update Posted : October 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Angina, Stable||Biological: Ad5FGF-4 Biological: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||320 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter, Phase 3 Study to Evaluate the Safety and Efficacy of Ad5FGF-4 in Patients With Refractory Angina Due to Myocardial Ischemia|
|Estimated Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||June 1, 2021|
|Estimated Study Completion Date :||January 1, 2022|
Experimental: A: Ad5FGF-4
Ad5FGF-4, administered one time at 6x10e9 viral particles in buffer, and maximally-tolerated medical therapy for angina.
Ad5FGF-4 administered via intracoronary infusion using standard balloon catheter, and under conditions of transient ischemia.
Placebo Comparator: B: Placebo
Placebo buffer, administered one time, and maximally-tolerated medical therapy for angina.
Placebo buffer administered via intracoronary infusion using standard balloon catheter, without transient ischemia.
- Change in Exercise Tolerance Test (ETT) duration [ Time Frame: Baseline and Month 6 ]Modified Bruce Protocol with exercise duration limited by angina grade 3 (patient feels chest pain that has increased to the point that he/she would stop activity and take nitroglycerin.
- Change in patient functional status (CCS class) [ Time Frame: Baseline and Months 6 and 12 ]Canadian Cardiovascular Society (CCS) angina classification
- Change in weekly angina frequency [ Time Frame: Baseline and Month 6 ]Average weekly angina episodes
- Change in weekly nitroglycerin usage [ Time Frame: Baseline and Month 6 ]Average weekly nitroglycerin usage
- Change in quality of life [ Time Frame: Baseline and Months 6 and 12 ]Seattle Angina Questionnaire
- Safety of Ad5FGF-4 [ Time Frame: Through Month 6 ]Adverse events and clinical laboratory testing
- Long-term safety of Ad5FGF-4 [ Time Frame: Through Month 60 ]Occurrence of clinically significant events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02928094
|Contact: Lois A Chandler, PhDfirstname.lastname@example.org|
|Contact: Christopher Reinhardemail@example.com|