Back to resultsEfficacy of Topical Capsaicin Cream for Stable Angina (TOPCAP)
Primary Purpose
Stable Angina
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Capsaicin
Placebo cream
Sponsored by
About this trial
This is an interventional treatment trial for Stable Angina
Eligibility 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
Sites / Locations
- University of Cincinnati Physicians, Inc
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
0.1% Capsaicin Cream
Placebo Cream
Arm Description
0.1% capsaicin cream spread 8cm x 15cm on abdomen, once, 45 minutes prior to exercise
Inactive cream, 4cm spread 8cm x 15cm on the abdomen, once, 45 minutes prior to exercise
Outcomes
Primary Outcome Measures
Symptom-limited Exercise Duration as an Indicator of Exercise Capacity
Subjects walked on the treadmill as long as they could tolerate, symptom-limited.
Time-to-onset of 1mm ST Segment Depression
Continuous ECG was recorded during exercise. ECG was reviewed by a board-certified cardiologist.
Time-to-onset of Angina or Angina Equivalent Symptoms
Onset of angina or angina-equivalent symptoms was assessed from beginning of exercise.
Maximal ST Depression
Exercise ECG data was reviewed by a board certified cardiologist to assess maximal ST depression.
Maximal Estimated Workload (in METS)
Maximal estimated workload (in METS) was measured during exercise tolerance test (ETT).
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01231750
First Posted
October 28, 2010
Last Updated
June 23, 2015
Sponsor
Neal Weintraub
Collaborators
University of Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT01231750
Brief Title
Efficacy of Topical Capsaicin Cream for Stable Angina
Acronym
TOPCAP
Official Title
A Randomized, Placebo-Controlled, Cross-Over Study to Assess the Safety and Efficacy of TOPical CAPsaicin With Stable Angina (TOPCAP)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
Unable to identify study population to achieve number expected
Study Start Date
October 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Neal Weintraub
Collaborators
University of Cincinnati
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Angina
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0.1% Capsaicin Cream
Arm Type
Active Comparator
Arm Description
0.1% capsaicin cream spread 8cm x 15cm on abdomen, once, 45 minutes prior to exercise
Arm Title
Placebo Cream
Arm Type
Placebo Comparator
Arm Description
Inactive cream, 4cm spread 8cm x 15cm on the abdomen, once, 45 minutes prior to exercise
Intervention Type
Drug
Intervention Name(s)
Capsaicin
Other Intervention Name(s)
capsaicin cream 0.1%, generic
Intervention Description
0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
Intervention Type
Other
Intervention Name(s)
Placebo cream
Other Intervention Name(s)
cream, placebo
Intervention Description
cream, 4cm spread over 8cm x 15cm area of skin
Primary Outcome Measure Information:
Title
Symptom-limited Exercise Duration as an Indicator of Exercise Capacity
Description
Subjects walked on the treadmill as long as they could tolerate, symptom-limited.
Time Frame
Application was 45 minutes prior to exercise
Title
Time-to-onset of 1mm ST Segment Depression
Description
Continuous ECG was recorded during exercise. ECG was reviewed by a board-certified cardiologist.
Time Frame
Application was 45 minutes prior to exercise
Title
Time-to-onset of Angina or Angina Equivalent Symptoms
Description
Onset of angina or angina-equivalent symptoms was assessed from beginning of exercise.
Time Frame
Application was 45 minutes prior to exercise
Title
Maximal ST Depression
Description
Exercise ECG data was reviewed by a board certified cardiologist to assess maximal ST depression.
Time Frame
Application was 45 minutes prior to exercise
Title
Maximal Estimated Workload (in METS)
Description
Maximal estimated workload (in METS) was measured during exercise tolerance test (ETT).
Time Frame
Application was 45 minutes prior to exercise
Title
Magnitude of Reversible Perfusion Defect in SPECT With Wall Motion Assessment (Phase 2)
Description
Phase 2 of the study involving nuclear imaging was not done because the study was stopped early for lack of enrollment.
Time Frame
Phase 2 was not done.
Title
Severity of Angina Was Measured.
Description
Severity of angina was measured using numerical score 1 to 10, where 10 is the worst intensity and 1 is the least.
Time Frame
Application was 45 minutes prior to exercise
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faisal M Khan, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati Physicians, Inc
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Topical Capsaicin Cream for Stable Angina
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