Efficacy of Topical Capsaicin Cream for Stable Angina (TOPCAP)

Neal Weintraub

Status and phase: Terminated; Phase 3

Conditions: Stable Angina

Treatments: Other: Placebo cream; Drug: Capsaicin

Study type: Interventional

Funder types: Other

Identifiers

NCT01231750

UC 060559

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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7 participants in 2 patient groups, including a placebo group

0.1% Capsaicin Cream

Active Comparator group

Description:

0.1% capsaicin cream spread 8cm x 15cm on abdomen, once, 45 minutes prior to exercise

Treatment:

Drug: Capsaicin

Placebo Cream

Placebo Comparator group

Description:

Inactive cream, 4cm spread 8cm x 15cm on the abdomen, once, 45 minutes prior to exercise

Treatment:

Other: Placebo cream