NCT07136012ClinicalTrials.gov
OCEAN(a)-PreEvent - Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction to Prevent First Major Cardiovascular Events
A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing Olpasiran Use to Prevent First Major Cardiovascular Events in Participants With Elevated Lipoprotein(a)
Kurz gefasst
The primary objective is to evaluate the effect of olpasiran, compared to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants at risk for a first major cardiovascular event with…
Phase 311.000 Teilnehmende gesucht252 Studienzentren3 Länder
Kategorien
In 1 Register registriert
- ClinicalTrials.govNCT07136012Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert vor 4 Wochen
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How this study is set up
The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.
- Present: Registered before enrolment beganFirst posted 2025-08-22; recorded start 2025-08-22
- Present: Has a defined primary outcomeA primary outcome measure is listed in the record
- Present: The primary outcome states a time frameThe primary outcome measure records a time frame
- Present: Participants are randomly assignedAllocation is recorded as randomised
- Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
- Present: Uses blinding (masking)A masking level is recorded in the record
- Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
- Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
- Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
- Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
- Present: Sponsor has 303 other studies in this databaseCounted from the lead sponsor named in the record (Amgen)
- Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
- The record lists 1 condition.
- Lead sponsor type recorded as: industry.
- Intervention regulatory context: investigational, within a phased regulatory pathway.
Trial stature
Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.
A definitive-grade design for a phase 3 study, judged from its ClinicalTrials.gov record.
How this score is built
- Randomised allocation20/20
Participants are randomly allocated between arms
- Blinding13/20
Double-blind
- Control arm13/15
Placebo / sham control arm
- Primary-outcome specificity10/10
Named primary outcome with a defined time frame
- Endpoint type10/10
Mortality / MACE endpoint (hard clinical outcome)
- Multi-centre8/8
Multi-centre: 249 sites
- Data monitoring committee7/7
A data monitoring committee is in place
- Prospective registration5/5
Registered before the study start date
- Protocol / SAP posted0/5
No protocol or SAP posted to the registry
A very large study, international in scope: 11,000 participants (target), run at 252 sites, across 3 countries.
How this score is built
- Enrolment38/40
11,000 participants (target)
- Site count25/25
249 sites
- Country count7/15
3 countries
- Planned duration10/10
Planned over about 75 months
- Sponsor scale9/10
Amgen has led 300 trials in our corpus
We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.
How this score is built
- Investigator standing0/100
No investigator recorded in the registry for this trial
These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.
Zusammenfassung
The primary objective is to evaluate the effect of olpasiran, compared to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants at risk for a first major cardiovascular event with elevated lipoprotein(a) (Lp\[a\]).
Erkrankungen
- Cardiovascular Disease
Eignung
| Geschlecht | Alle |
|---|---|
| Alter | 50 Years – 105 Years |
| Gesunde Freiwillige | Nein |
Eignung im Wortlaut des Registers
Eignung in einfachen Aussagen
Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.
Studiendesign
| Studientyp | Interventionell |
|---|---|
| Phase | Phase 3 |
| Zuteilung | Randomisiert |
| Interventionsmodell | PARALLEL |
| Primäres Ziel | TREATMENT |
| Verblindung | DOUBLE (2) |
| Teilnahme | 11.000 Teilnehmende gesucht |
Sponsor und Mitwirkende
- Amgen Sponsor
Studienarme und Interventionen
- OlpasiranEXPERIMENTAL
Participants will receive subcutaneous (SC) olpasiran.
- PlaceboPLACEBO_COMPARATOR
Participants will receive SC placebo.
Interventionen
- Arzneimittel Olpasiran
Olpasiran will be administered via SC injection.
- Arzneimittel Placebo
Placebo will be administered via SC injection.
Endpunkte
Primärer Endpunkt
Time to CHD Death, Myocardial Infarction, or Urgent Coronary Revascularization, Whichever Occurs First
Zeitrahmen Up to approximately 6.2 years
Sekundärer Endpunkt
Time to Cardiovascular Death, Myocardial Infarction, or Ischemic Stroke, Whichever Occurs First
Zeitrahmen Up to approximately 6.2 years
Sekundärer Endpunkt
Time to Cardiovascular Death, Myocardial Infarction, Urgent Coronary Revascularization, or Ischemic Stroke, Whichever Occurs First
Zeitrahmen Up to approximately 6.2 years
Sekundärer Endpunkt
Percent Change From Baseline to Week 48 Lp(a) Levels
Zeitrahmen Baseline and Week 48
Sekundärer Endpunkt
Time to Myocardial Infarction
Zeitrahmen Up to approximately 6.2 years
Sekundärer Endpunkt
Time to CHD Death or Myocardial Infarction, Whichever Occurs First
Zeitrahmen Up to approximately 6.2 years
Sekundärer Endpunkt
Time to Urgent Coronary Revascularization
Zeitrahmen Up to approximately 6.2 years
Sekundärer Endpunkt
Time to Coronary Revascularization
Zeitrahmen Up to approximately 6.2 years
Sekundärer Endpunkt
Time to CHD Death
Zeitrahmen Up to approximately 6.2 years
Sekundärer Endpunkt
Time to Cardiovascular Death
Zeitrahmen Up to approximately 6.2 years
Sekundärer Endpunkt
Time to Death by any Cause
Zeitrahmen Up to approximately 6.2 years
Sekundärer Endpunkt
Time to Ischemic Stroke
Zeitrahmen Up to approximately 6.2 years
Sekundärer Endpunkt
Serum Concentration of Olpasiran
Zeitrahmen Up to Week 48
Sekundärer Endpunkt
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Including serious adverse events and adverse events leading to discontinuation of investigational product.
Zeitrahmen Up to approximately 6.2 years
Daten
| Startdatum | 22. August 2025 (tatsächlich) |
|---|---|
| Primärer Abschluss | 20. Oktober 2031 (geschätzt) |
| Abschluss | 20. Oktober 2031 (geschätzt) |
| Erstveröffentlichung | 22. August 2025 (tatsächlich) |
| Zuletzt aktualisiert | 21. August 2026 |
| Ergebnisse veröffentlicht | Im Registereintrag nicht angegeben |
| Status zuletzt bestätigt | August 2026 |
Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.
Standorte
240 Studienzentren rekrutieren
Australia
| Einrichtung | Stadt | Bundesland oder Region | Status |
|---|---|---|---|
| Advara HeartCare Wesley | Auchenflower | Queensland | Rekrutiert |
| Flinders Medical Centre | Bedford Park | South Australia | Rekrutiert |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | Rekrutiert |
| Novatrials | Charlestown | New South Wales | Rekrutiert |
| Victorian Heart Hospital | Clayton | Victoria | Rekrutiert |
| Concord Repatriation General Hospital | Concord | New South Wales | Rekrutiert |
| Canberra Hospital | Garran | Australian Capital Territory | Rekrutiert |
| Clinitrials - Mandurah | Greenfields | Western Australia | Rekrutiert |
| Advara HeartCare Joondalup | Joondalup | Western Australia | Rekrutiert |
| Advara HeartCare Leabrook | Leabrook | South Australia | Rekrutiert |
| The Alfred Hospital | Melbourne | Victoria | Rekrutiert |
| Momentum Clinical Research - Sunshine | Melbourne | Victoria | Rekrutiert |
| Aim Research | Merewether | New South Wales | Rekrutiert |
| Core Research Group Pty Ltd | Milton | Queensland | Rekrutiert |
| Hollywood Private Hospital | Nedlands | Western Australia | Rekrutiert |
| Linear Clinical Research Limited | Nedlands | Western Australia | Rekrutiert |
| Fusion Clinical Research | Norwood | South Australia | Rekrutiert |
| Orange Health Service | Orange | New South Wales | Rekrutiert |
| Clinitrials - West Perth | Perth | Western Australia | Rekrutiert |
| University of The Sunshine Coast Clinical Trials, Sippy Downs | Sippy Downs | Queensland | Rekrutiert |
| Wollongong Hospital | Wollongong | New South Wales | Rekrutiert |
| Dr Heart Pty Ltd | Woolloongabba | Queensland | Rekrutiert |
Canada
| Einrichtung | Stadt | Bundesland oder Region | Status |
|---|---|---|---|
| Centricity Research Brampton | Brampton | Ontario | Rekrutiert |
| Circulate Cardiac & Vascular Centre | Burlington | Ontario | Rekrutiert |
| Centricity Research Calgary | Calgary | Alberta | Rekrutiert |
| Cambridge Cardiac Care Centre | Cambridge | Ontario | Rekrutiert |
| Ecogene-21 | Chicoutimi | Quebec | Rekrutiert |
| Edmonton Cardiology Consultants | Edmonton | Alberta | Rekrutiert |
| Premier Clinical Trial Network | Hamilton | Ontario | Abgeschlossen |
| Hamilton Health Sciences Hamilton General Hospital | Hamilton | Ontario | Rekrutiert |
| St Josephs Hospital | London | Ontario | Rekrutiert |
| Elevate Clinical Research KMH Missisauga | Mississauga | Ontario | Rekrutiert |
| Centre de Recherche du Centre Hospitalier de l Universite de Montreal | Montreal | Quebec | Rekrutiert |
| Research Institute of McGill University Health Center - Glen Site | Montreal | Quebec | Rekrutiert |
| Montreal Heart Institute | Montreal | Quebec | Rekrutiert |
| Institut de recherches cliniques de Montreal | Montreal | Quebec | Rekrutiert |
| Fraser Clinical Trials | New Westminster | British Columbia | Rekrutiert |
| Partners in Advanced Cardiac Evaluation | Newmarket | Ontario | Rekrutiert |
| North York Diagnostic and Cardiac Centre | North York | Ontario | Rekrutiert |
| Oakville Cardiovascular Research | Oakville | Ontario | Rekrutiert |
| Heart Health Institute Research Incorporated | Scarborough Village | Ontario | Rekrutiert |
| CIUSSS de l Estrie CHUS Hopital Fleurimont | Sherbrooke | Quebec | Rekrutiert |
| SMH Cardiology Clinical Trials Incorporated | Surrey | British Columbia | Rekrutiert |
| Womens College Hospital | Toronto | Ontario | Rekrutiert |
| ARC Biosystems Incorporated | Vancouver | British Columbia | Rekrutiert |
| Victoria Heart Institute Foundation | Victoria | British Columbia | Rekrutiert |
| Discovery Clinical Services Ltd | Victoria | British Columbia | Rekrutiert |
United States
| Einrichtung | Stadt | Bundesland oder Region | Status |
|---|---|---|---|
| Albany Medical College | Albany | New York | Rekrutiert |
| Advanced Cardiovascular LLC | Alexander City | Alabama | Rekrutiert |
| PharmaTex Research, LLC | Amarillo | Texas | Rekrutiert |
202 weitere Studienzentren sind im Registereintrag aufgeführt.
Studiendokumente
In diesem Registereintrag sind keine Dokumente verlinkt.
Änderungen im Zeitverlauf
- 13. August 2026
Studienzentrum hinzugefügt
1 site added (252 total)
251252
- 7. August 2026
Studienzentrum hinzugefügt
2 sites added (251 total)
249251