Coronary Artery Dissection, SpontaneousPhase 4SAFER-SCADNCT02008786
Statin and Angiotensin-converting Enzyme Inhibitor on Symptoms in Patients With SCAD
A Phase 4 study testing ramipril and rosuvastatin in people with Coronary Artery Dissection, Spontaneous, run by Cardiology Research UBC at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Coronary Artery Dissection, Spontaneous
- What is being tested?
- ramipril and rosuvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2014to 13 Sep 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
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.
Purpose:
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.
Hypothesis:
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.
- Conditions
- Coronary Artery Dissection, Spontaneous
- Being tested
- ramipril, rosuvastatin, placebo
- Keywords
- Coronary Artery Dissection, Spontaneous, Angina
- Medical subject headings
- Coronary Artery Dissection, Spontaneous, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ramiprilDrug
Also called Altace
5-10mg (starting dose 5mg titrating up to 10mg if tolerated after 1 week)
rosuvastatinDrug
Also called crestor
10-20mg (suggested dose 10mg for Asians, 20mg for everyone else)
placeboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin, placebo | Experimental | rosuvastatin 10-20mg daily or placebo (suggested dose of 10mg for Asians, and 20mg for others) Receives: 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 Receives: Drug: ramipril; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks after each intervention
Secondary outcomes (1)
Acute coronary syndrome or hospitalization for angina
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startJun 2014
- Primary completion13 Sep 2019
- Study completion13 Sep 2019
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Dissection, SpontaneousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiology Research UBC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Tara Sedlak, Cardiology Research UBC
- Investigators
- Tara Sedlak, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008786
- Sponsor's protocol ID
- SAFER-SCAD
- Acronym
- SAFER-SCAD
- Status last verified
- Mar 2024
- First submitted
- 7 Dec 2013
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02008786
- Acronym / sponsor ID
- SAFER-SCAD / SAFER-SCAD
- Conditions
- Coronary Artery Dissection, Spontaneous
- Keywords
- Coronary Artery Dissection, Spontaneous, Angina
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Cardiology Research UBCUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- 13 Sep 2019 (actual)
- Study completion
- 13 Sep 2019 (actual)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Purpose:
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.
Hypothesis:
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin, placebo | Experimental | Drug: rosuvastatin, Drug: placeborosuvastatin 10-20mg daily or placebo (suggested dose of 10mg for Asians, and 20mg for others) |
| Ramipril, placebo | Experimental | Drug: ramipril, Drug: placeboramipril (starting dose of ramipril at 5mg daily titrating up to 10mg daily at 1 week if tolerated) versus placebo |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ramiprilAlso: Altace5-10mg (starting dose 5mg titrating up to 10mg if tolerated after 1 week) | Drug | Ramipril, placebo |
| rosuvastatinAlso: crestor10-20mg (suggested dose 10mg for Asians, 20mg for everyone else) | Drug | Rosuvastatin, placebo |
| placeboPlacebo | Drug | Ramipril, placebo, Rosuvastatin, placebo |
Primary outcome
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.
1 secondary outcome
Acute coronary syndrome or hospitalization for angina
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tara Sedlak, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ramipril and rosuvastatin in people with Coronary Artery Dissection, Spontaneous, run by Cardiology Research UBC at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angina frequency domain of the SAQ (time frame: 16 weeks after each intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.