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NCT04331535: GenoVA
The Genomic Medicine at VA Study
NA trial testing Polygenic risk score (PRS) in Coronary Artery Disease in 1,076 participants. Status unknown.
30 September 2025
Quick facts
| Lead sponsor | Boston VA Research Institute, Inc. |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | screening |
| Enrollment | 1,076 |
| Start date | 17 July 2020 |
| Primary completion | 30 September 2025 |
| Estimated completion | 30 September 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Polygenic risk score (PRS)
Conditions studied
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
- Atrial Fibrillation — all drugs for Atrial Fibrillation →
- Type 2 Diabetes — all drugs for Type 2 Diabetes →
- Colorectal Cancer — all drugs for Colorectal Cancer →
Sponsor
Boston VA Research Institute, Inc.
Who can join
Adults 50 to 70, any sex, with Coronary Artery Disease or Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This trial will determine the clinical effectiveness of polygenic risk score testing among patients at high genetic risk for at least one of six diseases (coronary artery disease, atrial fibrillation, type 2 diabetes mellitus, colorectal cancer, breast cancer, or prostate cancer), measured by time-to-diagnosis of prevalent or incident disease over 24 months.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Development of a clinical polygenic risk score assay and reporting workflow.
Hao L, Kraft P, Berriz GF, Hynes ED, et al · · 2022 · cited 159× · PMID 35437332 · DOI 10.1038/s41591-022-01767-6 -
Clinical utility of polygenic risk scores for coronary artery disease.
Klarin D, Natarajan P. · · 2022 · cited 118× · PMID 34811547 · DOI 10.1038/s41569-021-00638-w -
The GenoVA study: Equitable implementation of a pragmatic randomized trial of polygenic-risk scoring in primary care.
Vassy JL, Brunette CA, Lebo MS, MacIsaac K, et al · · 2023 · cited 21× · PMID 37922883 · DOI 10.1016/j.ajhg.2023.10.001 -
Performance of EHR classifiers for patient eligibility in a clinical trial of precision screening.
Alexander NVJ, Brunette CA, Guardino ET, Yi T, et al · · 2022 · cited 3× · PMID 36115637 · DOI 10.1016/j.cct.2022.106926
Verify or expand the search:
- PubMed search for NCT04331535
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Boston VA Research Institute, Inc. trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04331535 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Boston VA Research Institute, Inc.
- Last refreshed: 3 October 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04331535.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing