VasculopathyPhase 2CAVIARNCT03537742

Cardiac Allograft Vasculopathy Inhibition With Alirocumab

A Phase 2 study testing alirocumab in people with Vasculopathy, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The focus of this study is to test the safety and efficacy of the PCSK9 inhibitor, alirocumab when administered early after heart transplantation (HT).The main objective of this project is to test the safety and impact on cardiac allograft vasculopathy (CAV) of alirocumab when given early after HT. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Vasculopathy
What is being tested?: alirocumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 114 participants
Where: 1 siteUnited States
Study dates: 13 May 2019to 11 Jul 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Heart Transplant recipient

Who cannot join

impaired liver function

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University
Stanford, California, 94305

Other trials in United States

About this study

Official title: PCSK9 Inhibition After Heart Transplantation

Conditions: Vasculopathy
Being tested: alirocumab, placebo
Keywords: Heart Transplant
Medical subject headings: Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

alirocumabBiological
Also called Praluent
alirocumab 150mg Subcutaneous
placeboBiological
placebo to match alirocumab

Study groups in NCT03537742
Study group	Role	What they receive
alirocumab	Experimental	alirocumab 150mg subcutaneous every other week for one year following start of study drug Receives: Biological: alirocumab
placebo	Placebo comparator	placebo to match alirocumab every other week for one year following start of study drug Receives: Biological: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Plaque Volume
Coronary artery plaque volume (mm³) was assessed using intravascular ultrasound (IVUS) during coronary angiography. Measurements were obtained at baseline (prior to study drug randomization) and at 1 year following treatment. The outcome measure represents the change in plaque volume from baseline to 1 year.
Measured: Baseline to one year

Secondary outcomes (13)

Low-Density Lipoprotein Cholesterol (LDL-C) Levels
Low-density lipoprotein cholesterol (LDL-C) levels were assessed at baseline and at 1 year post-randomization to compare the lipid-lowering effectiveness of adding alirocumab to standard rosuvastatin therapy versus placebo. Results are reported as mean +/- standard deviation (SD).
Measured: Baseline and one year
Apolipoprotein B (ApoB)
Apolipoprotein B was measured in mg/dL at baseline and 1 year to evaluate the impact of alirocumab versus placebo on overall atherogenic particle burden.
Measured: Baseline and 1 year
Lipoprotein(a)
Lipoprotein(a) was measured at baseline and 1 year to assess the efficacy of alirocumab in lowering this specific lipid parameter.
Measured: Baseline and 1 year
Total Cholesterol
Total cholesterol was measured to assess the efficacy of alirocumab versus placebo on overall impact for this specific lipid parameter.
Measured: Baseline and one year
HDL Cholesterol
HDL cholesterol was measured to assess the efficacy of alirocumab versus placebo on overall impact for this specific lipid parameter.
Measured: Baseline and one year
Triglycerides
Triglycerides were measured to assess the efficacy of alirocumab versus placebo on overall impact for this specific lipid parameter.
Measured: Baseline and one year
High-sensitivity C-reactive Protein (Hs-CRP)
hs-CRP was measured to assess the efficacy of alirocumab versus placebo on overall impact for this specific lipid parameter
Measured: Baseline and one year
Fractional Flow Reserve (FFR)
FFR measures the exact severity of blood flow restriction in a narrowed coronary artery. It is calculated as the mean distal pressure divided by the mean proximal pressure during maximal hyperemia.
Measured: baseline and one year
Coronary Flow Reserve (CFR)
CFR is the ratio of maximal coronary blood flow to resting blood flow. It was calculated as the resting mean transit time divided by the hyperemic mean transit time.
Measured: Baseline and 1 year
Index of Microcirculatory Resistance (IMR)
IMR is used to assess the function of the coronary microvasculature. It is calculated as the hyperemic distal coronary pressure multiplied by the hyperemic mean transit time.
Measured: Baseline and 1 year
Lipid Core Burden Index (LCBI)
LCBI is a measure of the lipid content within the coronary artery wall. It is calculated as the fraction of valid pixels with a yellow (high lipid probability) signal >0.6, multiplied by 1000. Values range from 0 to 1000, where higher values indicate a greater lipid burden.
Measured: Baseline and 1 year
Maximum Lipid Core Burden Index in 4 mm (maxLCBI 4mm)
The maxLCBI 4-mm represents the highest lipid core burden index (LCBI) value within any contiguous 4-mm segment of the scanned coronary region, indicating the most lipid-rich portion of the plaque. Scores range from 0 to 1000. Higher scores indicate greater lipid burden (worse outcome), while lower scores indicate less lipid-rich plaque (better outcome).
Measured: Baseline and 1 year
Maximum Intimal Thickness (MIT)
Measured using intravascular ultrasound (IVUS), this represents the thickness of the innermost layer of the artery wall at its thickest point.
Measured: Baseline and 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 May 201911 Jul 2025

First posted25 May 2018
Study start13 May 2019
Primary completion11 Jul 2025
Study completion11 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for VasculopathyStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 114 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03537742
Sponsor's protocol ID: IRB-45975
Other IDs: 4R33HL139929
Acronym: CAVIAR
Status last verified: Nov 2025
First submitted: 15 May 2018
Last updated: 18 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Fearon WF, Terada K, Takahashi K, Skoda A, Luikart HI, Lamendola CA, Zimmermann FM, Hashikata T, Saito K, Yoshida A, Varr B, Knowles JW, Woo C, Honda Y, Teuteberg J, Khush KK. Cardiac Allograft Vasculopathy Inhibition With Alirocumab: The CAVIAR Trial. Circulation. 2026 Jan 6;153(1):7-17. doi: 10.1161/CIRCULATIONAHA.125.077603. Epub 2025 Nov 10.
PubMed 41212178

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)

All Vasculopathy trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PCSK9 Inhibition After Heart Transplantation
ClinicalTrials.gov ID: NCT03537742
Acronym / sponsor ID: CAVIAR / IRB-45975
Conditions: Vasculopathy
Keywords: Heart Transplant
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 114 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: 13 May 2019 (actual)
Primary completion: 11 Jul 2025 (actual)
Study completion: 11 Jul 2025 (actual)
First posted: 25 May 2018 (actual)
Results: Posted 18 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
alirocumab	Experimental	Biological: alirocumabalirocumab 150mg subcutaneous every other week for one year following start of study drug
placebo	Placebo comparator	Biological: placeboplacebo to match alirocumab every other week for one year following start of study drug

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Heart Transplant recipient

Key exclusion criteria (1 listed)

impaired liver function

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
alirocumabAlso: Praluentalirocumab 150mg Subcutaneous	Biological	alirocumab
placeboplacebo to match alirocumab	Biological	placebo

Primary outcome

Plaque Volume
Time frame: Baseline to one year
Coronary artery plaque volume (mm³) was assessed using intravascular ultrasound (IVUS) during coronary angiography. Measurements were obtained at baseline (prior to study drug randomization) and at 1 year following treatment. The outcome measure represents the change in plaque volume from baseline to 1 year.

13 secondary outcomes

Low-Density Lipoprotein Cholesterol (LDL-C) Levels
Time frame: Baseline and one year
Apolipoprotein B (ApoB)
Time frame: Baseline and 1 year
Lipoprotein(a)
Time frame: Baseline and 1 year
Total Cholesterol
Time frame: Baseline and one year
HDL Cholesterol
Time frame: Baseline and one year
Triglycerides
Time frame: Baseline and one year
High-sensitivity C-reactive Protein (Hs-CRP)
Time frame: Baseline and one year
Fractional Flow Reserve (FFR)
Time frame: baseline and one year
Coronary Flow Reserve (CFR)
Time frame: Baseline and 1 year
Index of Microcirculatory Resistance (IMR)
Time frame: Baseline and 1 year
Lipid Core Burden Index (LCBI)
Time frame: Baseline and 1 year
Maximum Lipid Core Burden Index in 4 mm (maxLCBI 4mm)
Time frame: Baseline and 1 year
Maximum Intimal Thickness (MIT)
Time frame: Baseline and 1 year

Results and safety

Results posted to the registry on 18 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Alirocumab	57	57
Placebo	57	57

Primary outcome: Plaque Volume

Time frame: Baseline to one year. Mean (Standard Deviation). Unit: mm^3

Measure	Alirocumab n = 57	Placebo n = 57
Baseline	176.3 (95.2)	173.7 (96.7)
One year	184.5 (105.4)	183.1 (109.8)

Population analysed: Intention-to-treat population.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: From randomization through 12 months follow-up. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Alirocumab	17 of 57 (29.8%)	0 of 57 (0%)	0 of 57
Placebo	24 of 57 (42.1%)	0 of 57 (0%)	0 of 57

Limitations and caveats (from the sponsor): The study was limited by a relatively small sample size and relatively short 12-month follow-up, reducing power to detect differences, particularly with lower than expected plaque progression in the placebo group. The primary IVUS-derived surrogate endpoint may not fully reflect clinical outcomes. Assessment was limited to the LAD artery. Larger studies with longer follow-up may be needed to determine effects on cardiac allograft vasculopathy and clinical events.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 41212178Fearon WF, Terada K, Takahashi K, Skoda A, Luikart HI, Lamendola CA, Zimmermann FM, Hashikata T, Saito K, Yoshida A, Varr B, Knowles JW, Woo C, Honda Y, Teuteberg J, Khush KK. Cardiac Allograft Vasculopathy Inhibition With Alirocumab: The CAVIAR Trial. Circulation. 2026 Jan 6;153(1):7-17. doi: 10.1161/CIRCULATIONAHA.125.077603. Epub 2025 Nov 10.

Related trials for Vasculopathy

Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)

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.

William F Fearon, MD principal investigator

Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing alirocumab in people with Vasculopathy, run by Stanford University at 1 site in United States.

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 18 Aug 2026. 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 United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Plaque Volume (time frame: Baseline to one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03537742, which also lists 1 linked publication.

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 18 Aug 2026.