Statin and Angiotensin-converting Enzyme Inhibitor on Symptoms in Patients With SCAD (SAFER-SCAD)
|ClinicalTrials.gov Identifier: NCT02008786|
Recruitment Status : Unknown
Verified July 2014 by Dr. Tara Sedlak, Cardiology Research UBC.
Recruitment status was: Recruiting
First Posted : December 11, 2013
Last Update Posted : March 26, 2015
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Dissection, Spontaneous||Drug: ramipril Drug: rosuvastatin Drug: placebo||Phase 4|
In patients with spontaneous coronary artery dissection (SCAD), many continue to have ongoing signs and symptoms of ischemia after the dissection has healed. Further, 1 in 5 women will experience recurrent SCAD in long-term follow-up. To date, no study has investigated the pathophysiologic mechanism behind ongoing symptoms or recurrence of SCAD, but microvascular coronary dysfunction (MCD) has been suggested. Coronary reactivity testing (CRT) is an invasive procedure currently being done in MCD patients as the gold standard technique. In particular, a coronary flow reserve (CFR) < 2.5 has been shown to be both diagnostic of the condition and prognostic of a 2 fold increased risk of cardiac events. Please see below for a detailed description of CRT. In brief, a dual temperature and pressure sensor tipped wire by Radi Medical Systems (St Jude Medical, St Paul, MN) will be placed into the dissected and non-dissected coronary arteries of the patient. This will measure CFR by thermodilution and will also allow the measurement of the index of microcirculatory resistance (IMR). IMR has been found to correlate well with true microvascular resistance.
In addition to a lack of diagnostic strategies, there is a paucity of research into therapeutic strategies. Most women are conservatively managed with medications, however, there is no consensus as to which pharmacologic therapies should be used. Case reports have suggested benefit with antiplatelet agents (e.g. aspirin) and beta-blockers (reduction of arterial wall shear stress). To date no study has investigated the effects of statins or Angiotensin Converting Enzyme Inhibitors (ACEIs) in SCAD patients. Both agents have been studied in the MCD population and been found to reduce angina frequency and improve CFR after 16 weeks.
To measuring the CFR and IMR in 40 SCAD patients with ongoing chest pain who are at least 3 months from their dissection to determine the proportion with microvascular dysfunction and to investigate prospectively whether the addition of an ACEI or a statin to usual care in patients with ongoing chest pain and a CFR <3.0 improves chest pain frequency by Seattle Angina Questionnaire (SAQ) at 16 weeks compared to placebo.
We hypothesize that the average CFR in patients at least 3 months out from their SCAD will be <2.5 and that their IMR will be abnormal. Further, we hypothesize that the addition of either an ACEI and/or statin will improve chest pain frequency by at least 20 points on the SAQ at 16 weeks compared to placebo.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effects of Statin and Angiotensin-converting Enzyme Inhibitor on Coronary Flow Reserve, indEx of Microcirculatory Resistance, and Symptoms in Patients With Spontaneous Coronary Artery Dissection (SAFER-SCAD) Study|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||June 2016|
U.S. FDA Resources
Experimental: Rosuvastatin, placebo
rosuvastatin 10-20mg daily or placebo (suggested dose of 10mg for Asians, and 20mg for others)
10-20mg (suggested dose 10mg for Asians, 20mg for everyone else)
Other Name: crestorDrug: placebo
Experimental: Ramipril, placebo
ramipril (starting dose of ramipril at 5mg daily titrating up to 10mg daily at 1 week if tolerated) versus placebo
5-10mg (starting dose 5mg titrating up to 10mg if tolerated after 1 week)
Other Name: AltaceDrug: placebo
- Angina frequency domain of the SAQ [ Time Frame: 16 weeks after each intervention ]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.
- Acute coronary syndrome or hospitalization for angina [ Time Frame: 1 year ]As a secondary objective, to evaluate whether ACEI or statin versus placebo reduces the combined endpoint of acute coronary syndrome (ACS) or hospitalization for angina at 52 weeks
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02008786
|Contact: Tara L Sedlak, MD||604-875-5487||Tara.Sedlak@vch.ca|
|Contact: Andrew Starovoytov, MD||604 875 email@example.com|
|Canada, British Columbia|
|Vancouver General Hospital||Recruiting|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|Contact: Tara L Sedlak, MD 604-875-5487 Tara.Sedlak@vch.ca|
|Principal Investigator: Jacqueline Saw, MD|
|Principal Investigator: Tara Sedlak, MD|
|Principal Investigator:||Tara Sedlak, MD||University of British Columbia|