VasculopathySToP-CAVNCT05251129
Statin InTensity to Prevent Coronary Artery Vasculopathy After Heart Transplantation
A study testing Atorvastatin 80 Mg Oral Tablet and Pravastatin 40 Mg Oral Tablet in people with Vasculopathy, run by Montefiore Medical Center.
Trial summary
The investigator's propose to conduct an open-label randomized controlled trial to determine if higher intensity statin (HS) can reduce CAV in comparison to lower intensity statin (LS) after HT. All consecutive patients that meet eligibility criteria will be approached for participation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Vasculopathy
- What is being tested?
- Atorvastatin 80 Mg Oral Tablet and Pravastatin 40 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Jun 2030
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Waitlisted for Heart Transplantation
- Capacity to provide informed consent
Who cannot join
- History of statin allergy or intolerance
- Hepatic dysfunction
- Redo Heart Transplant
- Awaiting combined heart and liver transplantation
About this study
Official title: Statin InTensity to Prevent Coronary Artery Vasculopathy After Heart Transplantation - SToP-CAV
The investigator's propose to conduct an open-label randomized controlled trial to determine if higher intensity statin (HS) can reduce CAV in comparison to lower intensity statin (LS) after HT. All consecutive patients that meet eligibility criteria will be approached for participation. After heart transplantation, participants (n=70) will be randomized in a 1:1 manner to either HS or LS. Study participation will be for 2 years from the time of randomization. Study outcomes will be compared by research staff blinded to statin group assignment.
Read the detailed description
Outcomes after heart transplantation (HT) are limited by development of coronary allograft vasculopathy (CAV). CAV comprises of macro- and microvascular coronary disease and is the third leading cause of graft dysfunction and late mortality following HT. The pathophysiology of CAV is multifactorial and major pathways that are implicated include inflammation and dyslipidemia. These pathways are inhibited by statins which serve as the mainstay of CAV prevention.
The International Society of Heart and Lung Transplantation (ISHLT) guidelines recommend administration of low intensity statins (LS) due to a potential drug-drug interaction (DDI) with calcineurin inhibition (CNI) therapy. This DDI is related to concurrent use of an older generation CNI, cyclosporin A (CsA). CsA inhibits intestinal P-glycoprotein to reduce the efflux of statin into the gastrointestinal tract, thereby increasing statin levels in the blood and risk of myopathy. However, the current generation of CNI being utilized in most patients, Tacrolimus, does not inhibit P glycoprotein and may not impact statin levels after HT.
Despite use of LS, the residual risk of CAV development is elevated with nearly half of the patients having angiographic detection 5 years after HT. However, angiography is limited by its inability to detect microvascular disease and invasiveness. Early CAV is also detectable by non-invasive imaging with cardiac positron emission tomography (cPET) through measurement of myocardial flow reserve (MFR). MFR assesses total burden of macro- and microvascular disease and is well correlated with invasive measures of CAV and prognosis.
The protective and inhibitory effects of statins are proportional to their intensity with higher intensity statins (HS) leading to a greater reduction in low density lipoprotein (LDL) and inflammatory markers such as C-reactive protein (CRP) in comparison to LS. Despite these potentially beneficial effects of HS, LS remains the agent of choice for primary prevention of CAV after HT in the absence of a randomized controlled trial (RCT).
- Conditions
- Vasculopathy
- Being tested
- Atorvastatin 80 Mg Oral Tablet, Pravastatin 40 Mg Oral Tablet
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 80 Mg Oral TabletDrug
Higher intensity statin
Pravastatin 40 Mg Oral TabletDrug
Lower intensity statin
| Study group | Role | What they receive |
|---|---|---|
| Higher Intensity Statin | Experimental | Atorvastatin 80 milligram (mg) oral tablet Receives: Drug: Atorvastatin 80 Mg Oral Tablet |
| Lower Intensity Statin | Active comparator | Pravastatin 40 mg oral tablet Receives: Drug: Pravastatin 40 Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial Flow Reserve
Myocardial Flow Reserve measured by cardiac positron emission tomography
Measured: 2 year
Secondary outcomes (4)
Coronary Vascular Resistance
Coronary Vascular Resistance measured by cardiac positron emission tomography
Measured: 2 year
Change in Global Longitudinal Strain
Change in Global Longitudinal Strain measured by echocardiography
Measured: baseline, 1 year and 2 year
Blood level of Low Density Lipoprotein
Blood level of Low Density Lipoprotein
Measured: baseline, 6, 12, 18, 24 months
Blood level of High Sensitivity C-Reactive Protein
Blood level of High Sensitivity C-Reactive Protein
Measured: baseline, 6, 12, 18, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study startJan 2025 (estimated)
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
Why it stopped: Study never submitted. Study team instead conducted a retrospective study which did not qualify for registration.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VasculopathyStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Omar Saeed, MD, MS, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251129
- Sponsor's protocol ID
- 2021-13700
- Acronym
- SToP-CAV
- Status last verified
- Jan 2025
- First submitted
- 17 Dec 2021
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statin InTensity to Prevent Coronary Artery Vasculopathy After Heart Transplantation - SToP-CAV
- ClinicalTrials.gov ID
- NCT05251129
- Acronym / sponsor ID
- SToP-CAV / 2021-13700
- Conditions
- Vasculopathy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never submitted. Study team instead conducted a retrospective study which did not qualify for registration.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 22 Feb 2022 (actual)
- 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.
The investigator's propose to conduct an open-label randomized controlled trial to determine if higher intensity statin (HS) can reduce CAV in comparison to lower intensity statin (LS) after HT. All consecutive patients that meet eligibility criteria will be approached for participation. After heart transplantation, participants (n=70) will be randomized in a 1:1 manner to either HS or LS. Study participation will be for 2 years from the time of randomization. Study outcomes will be compared by research staff blinded to statin group assignment.
Detailed description
Outcomes after heart transplantation (HT) are limited by development of coronary allograft vasculopathy (CAV). CAV comprises of macro- and microvascular coronary disease and is the third leading cause of graft dysfunction and late mortality following HT. The pathophysiology of CAV is multifactorial and major pathways that are implicated include inflammation and dyslipidemia. These pathways are inhibited by statins which serve as the mainstay of CAV prevention.
The International Society of Heart and Lung Transplantation (ISHLT) guidelines recommend administration of low intensity statins (LS) due to a potential drug-drug interaction (DDI) with calcineurin inhibition (CNI) therapy. This DDI is related to concurrent use of an older generation CNI, cyclosporin A (CsA). CsA inhibits intestinal P-glycoprotein to reduce the efflux of statin into the gastrointestinal tract, thereby increasing statin levels in the blood and risk of myopathy. However, the current generation of CNI being utilized in most patients, Tacrolimus, does not inhibit P glycoprotein and may not impact statin levels after HT.
Despite use of LS, the residual risk of CAV development is elevated with nearly half of the patients having angiographic detection 5 years after HT. However, angiography is limited by its inability to detect microvascular disease and invasiveness. Early CAV is also detectable by non-invasive imaging with cardiac positron emission tomography (cPET) through measurement of myocardial flow reserve (MFR). MFR assesses total burden of macro- and microvascular disease and is well correlated with invasive measures of CAV and prognosis.
The protective and inhibitory effects of statins are proportional to their intensity with higher intensity statins (HS) leading to a greater reduction in low density lipoprotein (LDL) and inflammatory markers such as C-reactive protein (CRP) in comparison to LS. Despite these potentially beneficial effects of HS, LS remains the agent of choice for primary prevention of CAV after HT in the absence of a randomized controlled trial (RCT).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Open-label, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Higher Intensity Statin | Experimental | Drug: Atorvastatin 80 Mg Oral TabletAtorvastatin 80 milligram (mg) oral tablet |
| Lower Intensity Statin | Active comparator | Drug: Pravastatin 40 Mg Oral TabletPravastatin 40 mg oral tablet |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Waitlisted for Heart Transplantation
- Capacity to provide informed consent
Key exclusion criteria (4 listed)
- History of statin allergy or intolerance
- Hepatic dysfunction
- Redo Heart Transplant
- Awaiting combined heart and liver transplantation
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 |
|---|---|---|
| Atorvastatin 80 Mg Oral TabletHigher intensity statin | Drug | Higher Intensity Statin |
| Pravastatin 40 Mg Oral TabletLower intensity statin | Drug | Lower Intensity Statin |
Primary outcome
Myocardial Flow Reserve
Time frame: 2 year
Myocardial Flow Reserve measured by cardiac positron emission tomography
4 secondary outcomes
Coronary Vascular Resistance
Time frame: 2 year
Change in Global Longitudinal Strain
Time frame: baseline, 1 year and 2 year
Blood level of Low Density Lipoprotein
Time frame: baseline, 6, 12, 18, 24 months
Blood level of High Sensitivity C-Reactive Protein
Time frame: baseline, 6, 12, 18, 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
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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.
Omar Saeed, MD, MS principal investigator
Montefiore Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Atorvastatin 80 Mg Oral Tablet and Pravastatin 40 Mg Oral Tablet in people with Vasculopathy, run by Montefiore Medical Center.
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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Myocardial Flow Reserve (time frame: 2 year). 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 13 Jan 2025.