Efficacy of Topical Capsaicin Cream for Stable Angina
Information source: University of Cincinnati
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stable Angina
Intervention: Capsaicin (Drug); Placebo cream (Other)
Phase: Phase 3
Status: Terminated
Sponsored by: Neal Weintraub Official(s) and/or principal investigator(s): Faisal M Khan, MD, Principal Investigator, Affiliation: University of Cincinnati
Summary
The purpose of this study is to test the hypothesis that application of topical capsaicin in
patients with stable angina will result in improved exercise tolerance and reduced cardiac
ischemia.
Clinical Details
Official title: A Randomized, Placebo-Controlled, Cross-Over Study to Assess the Safety and Efficacy of TOPical CAPsaicin With Stable Angina (TOPCAP)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Symptom-limited Exercise Duration as an Indicator of Exercise CapacityTime-to-onset of 1mm ST Segment Depression Time-to-onset of Angina or Angina Equivalent Symptoms Maximal ST Depression Maximal Estimated Workload (in METS) Magnitude of Reversible Perfusion Defect in SPECT With Wall Motion Assessment (Phase 2) Severity of Angina Was Measured.
Detailed description:
Patients with stable angina on medical therapy who are capable of exercising on a treadmill
and have an interpretable ECG for ischemia will be enrolled in the study, which entails
performing two treadmill tests approximately one week apart following topical treatment with
placebo cream or topical capsaicin (randomized in crossover fashion). Patients will be
monitored for exercise tolerance, anginal symptoms, ECG for ischemia/arrhythmia, and
hemodynamic responses.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- > or = 3 month history of chronic, stable, angina triggered by physical effort or
mental/emotional stress
- documented stress-induced ST depression, reversible perfusion imaging, or wall motion
abnormality or CAD >50%
- Canadian Cardiovascular (CV) Class I-III
- Receiving medical therapy for > or = 2 months
- Ability to perform Bruce Protocol treadmill test
- non-pregnant female
Exclusion Criteria:
- unstable angina
- revasc within 2 months
- Myocardial infarction (MI) within 2 months
- congestive heart failure (CHF) hospitalization within 2 months
- New York Heart Association (NYHA) class III or IV
- left ventricular ejection fraction (LVEF) < 25%
- abnormal ECG; Acute changes on ECG
- Currently receiving treatment with investigational drugs/devices
- Uncontrolled hypertension
- contraindication to exercise stress testing
- allergy to red peppers or capsaicin
- skin deformity, scar, or rash at application site
- abdominal surgery within 3 months
Locations and Contacts
University of Cincinnati Physicians, Inc, Cincinnati, Ohio 45219, United States
Additional Information
Starting date: October 2010
Last updated: June 23, 2015
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