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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


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 Capacity

Time-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.


Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.


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

Page last updated: August 20, 2015

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