Statin and Angiotensin-converting Enzyme Inhibitor on Symptoms in Patients With SCAD

NCT02008786 | Terminated Phase 4

• 1 other identifier: SAFER-SCAD
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

An emerging cause of heart attack in young women is a dissection (or tear) in the coronary arteries. Many of these young women continue to have chest pain long after the tear has healed and this is thought to be due to problems with their small blood vessels of the heart (or microcirculation). We want to determine whether commonly used medications for coronary artery disease including statins (for cholesterol) and angiotensin-converting enzyme inhibitors (for blood pressure) reduce chest pain and improve small vessel function in these patients.

Conditions

Coronary Artery Dissection, Spontaneous

Keywords

Coronary Artery Dissection, Spontaneous; Angina

Outcome Measures

Primary Outcomes (1)

• Angina frequency domain of the SAQ

  Angina frequency domain of the SAQ, collected at baseline and after each intervention to assess angina frequency change over time. We hypothesize that mean SAQ will improve by at least 20 points in each treatment group compared to placebo.

  16 weeks after each intervention

Secondary Outcomes (1)

• Acute coronary syndrome or hospitalization for angina

  1 year

Study Arms (2)

Rosuvastatin, placebo

EXPERIMENTAL

rosuvastatin 10-20mg daily or placebo (suggested dose of 10mg for Asians, and 20mg for others)

Drug: rosuvastatin; Drug: placebo

Ramipril, placebo

EXPERIMENTAL

ramipril (starting dose of ramipril at 5mg daily titrating up to 10mg daily at 1 week if tolerated) versus placebo

Drug: ramipril; Drug: placebo

Interventions

ramipril DRUG

5-10mg (starting dose 5mg titrating up to 10mg if tolerated after 1 week)

Also known as: Altace

Ramipril, placebo

rosuvastatin DRUG

10-20mg (suggested dose 10mg for Asians, 20mg for everyone else)

Also known as: crestor

Rosuvastatin, placebo

placebo DRUG

Placebo

Ramipril, placebo; Rosuvastatin, placebo

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Any woman with prior SCAD who is at least 3 months out from her SCAD and has ongoing symptoms of chest pain.
• Females of child-bearing age must have a negative pregnancy test at enrollment
• Coronary Flow Reserve(CFR) \< 3.0

You may not qualify if:

• Renal dysfunction with Glomerular Filtration Rate \<50 ml/min
• Patients not willing to undergo coronary angiography
• Patients with a prior intolerance or allergy to rosuvastatin or ramipril
• Inability to perform CRT or CFR \>3.0
• Obstructive coronary artery disease (stenosis \>50% in any artery) or residual dissection \>50% with distal flow abnormalities

Sponsors & Collaborators

• Cardiology Research UBC: lead

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

Coronary Artery Dissection, Spontaneous; Angina Pectoris

Interventions

Ramipril; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Tara Sedlak, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist

Study Record Dates

• First Submitted: December 7, 2013
• First Posted: December 11, 2013
• Study Start: June 1, 2014
• Primary Completion: September 13, 2019
• Study Completion: September 13, 2019
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

CA (1)