Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 4R33HL139929 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| alirocumab | Experimental | alirocumab 150mg subcutaneous every other week for one year following start of study drug |
|
| placebo | Placebo Comparator | placebo to match alirocumab every other week for one year following start of study drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alirocumab | Biological | alirocumab 150mg Subcutaneous |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in volume of plaque at 1 year post study drug start post heart transplant | Measured change in coronary artery plaque volume(MM3), measured by Intravascular Ultrasound at time of coronary arteriogram within 4-8 weeks post transplant( baseline) and one year after study drug start post transplant | Baseline and one year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in LDL-C | measure differences in LDL-C lipid particle values between the two arms at baseline, 3, 6 and 12 months | Baseline, 3, 6 and 12 months |
| Change in lipoprotein (a) | measure differences lipid particle lipoprotein (a) values between the two arms at Baseline, 3, 6 and 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| William F Fearon, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41212178 | Result | 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. |
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 14, 2021 | Feb 25, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 23, 2024 | Mar 12, 2026 | ICF_001.pdf |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 12, 2026 | Jul 9, 2026 | 8 |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C571059 | alirocumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo | Biological | placebo to match alirocumab |
|
| Baseline, 3, 6 and 12 |
| Change in apolipoprotein B | measure differences in apolipoprotein B lipid particle apolipoprotein B values between the two arms at baseline, 3, 6 and 12 months | Baseline, 3, 6 and 12 |
| Percent change in coronary vessel size by fractional flow reserve | evaluate the ability of fractional flow reserve (% change in vessel size) to predict clinically meaningful increases in plaque volume one year post-transplant relative to that of plaque volume measured via intravascular ultrasound at baseline | baseline and one year |