Efficacy of Topical Capsaicin Cream for Stable Angina (TOPCAP)

A Randomized, Placebo-Controlled, Cross-Over Study to Assess the Safety and Efficacy of TOPical CAPsaicin With Stable Angina (TOPCAP)

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.

Study Overview

• Status: Terminated
• Conditions: Stable Angina
• Intervention / Treatment: Drug: Capsaicin; Other: Placebo cream

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati Physicians, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 0.1% Capsaicin Cream; 0.1% capsaicin cream spread 8cm x 15cm on abdomen, once, 45 minutes prior to exercise	Drug: Capsaicin; 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise; Other Names: capsaicin cream 0.1%, generic
Placebo Comparator: Placebo Cream; Inactive cream, 4cm spread 8cm x 15cm on the abdomen, once, 45 minutes prior to exercise	Other: Placebo cream; cream, 4cm spread over 8cm x 15cm area of skin; Other Names: cream, placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom-limited Exercise Duration as an Indicator of Exercise Capacity	Subjects walked on the treadmill as long as they could tolerate, symptom-limited.	Application was 45 minutes prior to exercise
Time-to-onset of 1mm ST Segment Depression	Continuous ECG was recorded during exercise. ECG was reviewed by a board-certified cardiologist.	Application was 45 minutes prior to exercise
Time-to-onset of Angina or Angina Equivalent Symptoms	Onset of angina or angina-equivalent symptoms was assessed from beginning of exercise.	Application was 45 minutes prior to exercise
Maximal ST Depression	Exercise ECG data was reviewed by a board certified cardiologist to assess maximal ST depression.	Application was 45 minutes prior to exercise
Maximal Estimated Workload (in METS)	Maximal estimated workload (in METS) was measured during exercise tolerance test (ETT).	Application was 45 minutes prior to exercise
Magnitude of Reversible Perfusion Defect in SPECT With Wall Motion Assessment (Phase 2)	Phase 2 of the study involving nuclear imaging was not done because the study was stopped early for lack of enrollment.	Phase 2 was not done.
Severity of Angina Was Measured.	Severity of angina was measured using numerical score 1 to 10, where 10 is the worst intensity and 1 is the least.	Application was 45 minutes prior to exercise

Collaborators and Investigators

• Sponsor: Neal Weintraub
• Collaborators: University of Cincinnati
• Investigators: Principal Investigator: Faisal M Khan, MD, University of Cincinnati

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: October 28, 2010
• First Submitted That Met QC Criteria: October 29, 2010
• First Posted (Estimate): November 1, 2010

Study Record Updates

• Last Update Posted (Estimate): June 25, 2015
• Last Update Submitted That Met QC Criteria: June 23, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Angina, Stable; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Dermatologic Agents; Antipruritics; Capsaicin
• Other Study ID Numbers: UC 060559