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)
בקצרה
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…
שלב 3דרושים 11,000 משתתפים252 אתרים3 מדינות
קטגוריות
רשום במרשם אחד
- ClinicalTrials.govNCT07136012פתיחת רשומה זו ב־ClinicalTrials.govסונכרן לפני 4 שבועות
מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.
מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.
מתעניינים במחקר הזה?
התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.
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.
תקציר
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\[a\]).
מצבים רפואיים
- Cardiovascular Disease
זכאות
| מין | הכול |
|---|---|
| גילאים | 50 Years – 105 Years |
| מתנדבים בריאים | לא |
זכאות כפי שנכתבה במרשם
זכאות במשפטים פשוטים
הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.
תכנון המחקר
| סוג המחקר | התערבותי |
|---|---|
| שלב | שלב 3 |
| הקצאה | אקראי |
| מודל ההתערבות | PARALLEL |
| מטרה ראשית | TREATMENT |
| הסתרה | DOUBLE (2) |
| גיוס | דרושים 11,000 משתתפים |
נותן חסות ושותפים
- Amgen נותן חסות
זרועות והתערבויות
- OlpasiranEXPERIMENTAL
Participants will receive subcutaneous (SC) olpasiran.
- PlaceboPLACEBO_COMPARATOR
Participants will receive SC placebo.
התערבויות
- תרופה Olpasiran
Olpasiran will be administered via SC injection.
- תרופה Placebo
Placebo will be administered via SC injection.
מדדי תוצאה
מדד תוצאה ראשוני
Time to CHD Death, Myocardial Infarction, or Urgent Coronary Revascularization, Whichever Occurs First
מסגרת זמן Up to approximately 6.2 years
מדד תוצאה משני
Time to Cardiovascular Death, Myocardial Infarction, or Ischemic Stroke, Whichever Occurs First
מסגרת זמן Up to approximately 6.2 years
מדד תוצאה משני
Time to Cardiovascular Death, Myocardial Infarction, Urgent Coronary Revascularization, or Ischemic Stroke, Whichever Occurs First
מסגרת זמן Up to approximately 6.2 years
מדד תוצאה משני
Percent Change From Baseline to Week 48 Lp(a) Levels
מסגרת זמן Baseline and Week 48
מדד תוצאה משני
Time to Myocardial Infarction
מסגרת זמן Up to approximately 6.2 years
מדד תוצאה משני
Time to CHD Death or Myocardial Infarction, Whichever Occurs First
מסגרת זמן Up to approximately 6.2 years
מדד תוצאה משני
Time to Urgent Coronary Revascularization
מסגרת זמן Up to approximately 6.2 years
מדד תוצאה משני
Time to Coronary Revascularization
מסגרת זמן Up to approximately 6.2 years
מדד תוצאה משני
Time to CHD Death
מסגרת זמן Up to approximately 6.2 years
מדד תוצאה משני
Time to Cardiovascular Death
מסגרת זמן Up to approximately 6.2 years
מדד תוצאה משני
Time to Death by any Cause
מסגרת זמן Up to approximately 6.2 years
מדד תוצאה משני
Time to Ischemic Stroke
מסגרת זמן Up to approximately 6.2 years
מדד תוצאה משני
Serum Concentration of Olpasiran
מסגרת זמן Up to Week 48
מדד תוצאה משני
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Including serious adverse events and adverse events leading to discontinuation of investigational product.
מסגרת זמן Up to approximately 6.2 years
תאריכים
| תאריך התחלה | 22 באוגוסט 2025 (בפועל) |
|---|---|
| סיום ראשוני | 20 באוקטובר 2031 (משוער) |
| סיום | 20 באוקטובר 2031 (משוער) |
| פורסם לראשונה | 22 באוגוסט 2025 (בפועל) |
| עודכן לאחרונה | 21 באוגוסט 2026 |
| התוצאות פורסמו | לא צוין ברשומת המרשם |
| המצב אומת לאחרונה | אוגוסט 2026 |
בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.
מיקומים
240 אתרים מגייסים
Australia
| מתקן | עיר | מדינה או אזור | מצב |
|---|---|---|---|
| Advara HeartCare Wesley | Auchenflower | Queensland | מגייס |
| Flinders Medical Centre | Bedford Park | South Australia | מגייס |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | מגייס |
| Novatrials | Charlestown | New South Wales | מגייס |
| Victorian Heart Hospital | Clayton | Victoria | מגייס |
| Concord Repatriation General Hospital | Concord | New South Wales | מגייס |
| Canberra Hospital | Garran | Australian Capital Territory | מגייס |
| Clinitrials - Mandurah | Greenfields | Western Australia | מגייס |
| Advara HeartCare Joondalup | Joondalup | Western Australia | מגייס |
| Advara HeartCare Leabrook | Leabrook | South Australia | מגייס |
| The Alfred Hospital | Melbourne | Victoria | מגייס |
| Momentum Clinical Research - Sunshine | Melbourne | Victoria | מגייס |
| Aim Research | Merewether | New South Wales | מגייס |
| Core Research Group Pty Ltd | Milton | Queensland | מגייס |
| Hollywood Private Hospital | Nedlands | Western Australia | מגייס |
| Linear Clinical Research Limited | Nedlands | Western Australia | מגייס |
| Fusion Clinical Research | Norwood | South Australia | מגייס |
| Orange Health Service | Orange | New South Wales | מגייס |
| Clinitrials - West Perth | Perth | Western Australia | מגייס |
| University of The Sunshine Coast Clinical Trials, Sippy Downs | Sippy Downs | Queensland | מגייס |
| Wollongong Hospital | Wollongong | New South Wales | מגייס |
| Dr Heart Pty Ltd | Woolloongabba | Queensland | מגייס |
Canada
| מתקן | עיר | מדינה או אזור | מצב |
|---|---|---|---|
| Centricity Research Brampton | Brampton | Ontario | מגייס |
| Circulate Cardiac & Vascular Centre | Burlington | Ontario | מגייס |
| Centricity Research Calgary | Calgary | Alberta | מגייס |
| Cambridge Cardiac Care Centre | Cambridge | Ontario | מגייס |
| Ecogene-21 | Chicoutimi | Quebec | מגייס |
| Edmonton Cardiology Consultants | Edmonton | Alberta | מגייס |
| Premier Clinical Trial Network | Hamilton | Ontario | הושלם |
| Hamilton Health Sciences Hamilton General Hospital | Hamilton | Ontario | מגייס |
| St Josephs Hospital | London | Ontario | מגייס |
| Elevate Clinical Research KMH Missisauga | Mississauga | Ontario | מגייס |
| Centre de Recherche du Centre Hospitalier de l Universite de Montreal | Montreal | Quebec | מגייס |
| Research Institute of McGill University Health Center - Glen Site | Montreal | Quebec | מגייס |
| Montreal Heart Institute | Montreal | Quebec | מגייס |
| Institut de recherches cliniques de Montreal | Montreal | Quebec | מגייס |
| Fraser Clinical Trials | New Westminster | British Columbia | מגייס |
| Partners in Advanced Cardiac Evaluation | Newmarket | Ontario | מגייס |
| North York Diagnostic and Cardiac Centre | North York | Ontario | מגייס |
| Oakville Cardiovascular Research | Oakville | Ontario | מגייס |
| Heart Health Institute Research Incorporated | Scarborough Village | Ontario | מגייס |
| CIUSSS de l Estrie CHUS Hopital Fleurimont | Sherbrooke | Quebec | מגייס |
| SMH Cardiology Clinical Trials Incorporated | Surrey | British Columbia | מגייס |
| Womens College Hospital | Toronto | Ontario | מגייס |
| ARC Biosystems Incorporated | Vancouver | British Columbia | מגייס |
| Victoria Heart Institute Foundation | Victoria | British Columbia | מגייס |
| Discovery Clinical Services Ltd | Victoria | British Columbia | מגייס |
United States
| מתקן | עיר | מדינה או אזור | מצב |
|---|---|---|---|
| Albany Medical College | Albany | New York | מגייס |
| Advanced Cardiovascular LLC | Alexander City | Alabama | מגייס |
| PharmaTex Research, LLC | Amarillo | Texas | מגייס |
202 אתרים נוספים מצוינים ברשומת המרשם.
מסמכי המחקר
לא צורפו מסמכים ברשומת מרשם זו.
שינויים לאורך זמן
- 13 באוגוסט 2026
אתר נוסף
1 site added (252 total)
251252
- 7 באוגוסט 2026
אתר נוסף
2 sites added (251 total)
249251