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)
باختصار
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…
المرحلة 3مطلوب 11,000 مشارك252 موقعاً3 دول
الفئات
مسجَّلة في سجل واحد
- ClinicalTrials.govNCT07136012فتح هذا السجل في ClinicalTrials.govتمت المزامنة قبل 4 أسابيع
يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.
تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.
هل أنت مهتم بهذه الدراسة؟
تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.
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.
ملخص
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\[a\]).
الحالات
- Cardiovascular Disease
الأهلية
| الجنس | الجميع |
|---|---|
| الأعمار | 50 Years – 105 Years |
| المتطوعون الأصحّاء | لا |
الأهلية كما كُتبت في السجل
الأهلية في عبارات بسيطة
لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.
تصميم الدراسة
| نوع الدراسة | تدخّلية |
|---|---|
| المرحلة | المرحلة 3 |
| التخصيص | معشّاة |
| نموذج التدخّل | PARALLEL |
| الغرض الأساسي | TREATMENT |
| التعمية | DOUBLE (2) |
| التجنيد | مطلوب 11,000 مشارك |
الجهة الراعية والمتعاونون
- Amgen الجهة الراعية
الأذرع والتدخلات
- OlpasiranEXPERIMENTAL
Participants will receive subcutaneous (SC) olpasiran.
- PlaceboPLACEBO_COMPARATOR
Participants will receive SC placebo.
التدخلات
- دواء Olpasiran
Olpasiran will be administered via SC injection.
- دواء Placebo
Placebo will be administered via SC injection.
مقاييس النتائج
مقياس النتيجة الأولي
Time to CHD Death, Myocardial Infarction, or Urgent Coronary Revascularization, Whichever Occurs First
الإطار الزمني Up to approximately 6.2 years
مقياس النتيجة الثانوي
Time to Cardiovascular Death, Myocardial Infarction, or Ischemic Stroke, Whichever Occurs First
الإطار الزمني Up to approximately 6.2 years
مقياس النتيجة الثانوي
Time to Cardiovascular Death, Myocardial Infarction, Urgent Coronary Revascularization, or Ischemic Stroke, Whichever Occurs First
الإطار الزمني Up to approximately 6.2 years
مقياس النتيجة الثانوي
Percent Change From Baseline to Week 48 Lp(a) Levels
الإطار الزمني Baseline and Week 48
مقياس النتيجة الثانوي
Time to Myocardial Infarction
الإطار الزمني Up to approximately 6.2 years
مقياس النتيجة الثانوي
Time to CHD Death or Myocardial Infarction, Whichever Occurs First
الإطار الزمني Up to approximately 6.2 years
مقياس النتيجة الثانوي
Time to Urgent Coronary Revascularization
الإطار الزمني Up to approximately 6.2 years
مقياس النتيجة الثانوي
Time to Coronary Revascularization
الإطار الزمني Up to approximately 6.2 years
مقياس النتيجة الثانوي
Time to CHD Death
الإطار الزمني Up to approximately 6.2 years
مقياس النتيجة الثانوي
Time to Cardiovascular Death
الإطار الزمني Up to approximately 6.2 years
مقياس النتيجة الثانوي
Time to Death by any Cause
الإطار الزمني Up to approximately 6.2 years
مقياس النتيجة الثانوي
Time to Ischemic Stroke
الإطار الزمني Up to approximately 6.2 years
مقياس النتيجة الثانوي
Serum Concentration of Olpasiran
الإطار الزمني Up to Week 48
مقياس النتيجة الثانوي
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Including serious adverse events and adverse events leading to discontinuation of investigational product.
الإطار الزمني Up to approximately 6.2 years
التواريخ
| تاريخ البدء | 22 أغسطس 2025 (فعلي) |
|---|---|
| الإتمام الأولي | 20 أكتوبر 2031 (تقديري) |
| الإتمام | 20 أكتوبر 2031 (تقديري) |
| أول نشر | 22 أغسطس 2025 (فعلي) |
| آخر تحديث | 21 أغسطس 2026 |
| النتائج منشورة | غير مذكور في سجل السجل |
| آخر تأكيد للحالة | أغسطس 2026 |
فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.
المواقع
240 موقعاً قيد التجنيد
Australia
| المنشأة | المدينة | الولاية أو المنطقة | الحالة |
|---|---|---|---|
| Advara HeartCare Wesley | Auchenflower | Queensland | قيد التجنيد |
| Flinders Medical Centre | Bedford Park | South Australia | قيد التجنيد |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | قيد التجنيد |
| Novatrials | Charlestown | New South Wales | قيد التجنيد |
| Victorian Heart Hospital | Clayton | Victoria | قيد التجنيد |
| Concord Repatriation General Hospital | Concord | New South Wales | قيد التجنيد |
| Canberra Hospital | Garran | Australian Capital Territory | قيد التجنيد |
| Clinitrials - Mandurah | Greenfields | Western Australia | قيد التجنيد |
| Advara HeartCare Joondalup | Joondalup | Western Australia | قيد التجنيد |
| Advara HeartCare Leabrook | Leabrook | South Australia | قيد التجنيد |
| The Alfred Hospital | Melbourne | Victoria | قيد التجنيد |
| Momentum Clinical Research - Sunshine | Melbourne | Victoria | قيد التجنيد |
| Aim Research | Merewether | New South Wales | قيد التجنيد |
| Core Research Group Pty Ltd | Milton | Queensland | قيد التجنيد |
| Hollywood Private Hospital | Nedlands | Western Australia | قيد التجنيد |
| Linear Clinical Research Limited | Nedlands | Western Australia | قيد التجنيد |
| Fusion Clinical Research | Norwood | South Australia | قيد التجنيد |
| Orange Health Service | Orange | New South Wales | قيد التجنيد |
| Clinitrials - West Perth | Perth | Western Australia | قيد التجنيد |
| University of The Sunshine Coast Clinical Trials, Sippy Downs | Sippy Downs | Queensland | قيد التجنيد |
| Wollongong Hospital | Wollongong | New South Wales | قيد التجنيد |
| Dr Heart Pty Ltd | Woolloongabba | Queensland | قيد التجنيد |
Canada
| المنشأة | المدينة | الولاية أو المنطقة | الحالة |
|---|---|---|---|
| Centricity Research Brampton | Brampton | Ontario | قيد التجنيد |
| Circulate Cardiac & Vascular Centre | Burlington | Ontario | قيد التجنيد |
| Centricity Research Calgary | Calgary | Alberta | قيد التجنيد |
| Cambridge Cardiac Care Centre | Cambridge | Ontario | قيد التجنيد |
| Ecogene-21 | Chicoutimi | Quebec | قيد التجنيد |
| Edmonton Cardiology Consultants | Edmonton | Alberta | قيد التجنيد |
| Premier Clinical Trial Network | Hamilton | Ontario | مكتمل |
| Hamilton Health Sciences Hamilton General Hospital | Hamilton | Ontario | قيد التجنيد |
| St Josephs Hospital | London | Ontario | قيد التجنيد |
| Elevate Clinical Research KMH Missisauga | Mississauga | Ontario | قيد التجنيد |
| Centre de Recherche du Centre Hospitalier de l Universite de Montreal | Montreal | Quebec | قيد التجنيد |
| Research Institute of McGill University Health Center - Glen Site | Montreal | Quebec | قيد التجنيد |
| Montreal Heart Institute | Montreal | Quebec | قيد التجنيد |
| Institut de recherches cliniques de Montreal | Montreal | Quebec | قيد التجنيد |
| Fraser Clinical Trials | New Westminster | British Columbia | قيد التجنيد |
| Partners in Advanced Cardiac Evaluation | Newmarket | Ontario | قيد التجنيد |
| North York Diagnostic and Cardiac Centre | North York | Ontario | قيد التجنيد |
| Oakville Cardiovascular Research | Oakville | Ontario | قيد التجنيد |
| Heart Health Institute Research Incorporated | Scarborough Village | Ontario | قيد التجنيد |
| CIUSSS de l Estrie CHUS Hopital Fleurimont | Sherbrooke | Quebec | قيد التجنيد |
| SMH Cardiology Clinical Trials Incorporated | Surrey | British Columbia | قيد التجنيد |
| Womens College Hospital | Toronto | Ontario | قيد التجنيد |
| ARC Biosystems Incorporated | Vancouver | British Columbia | قيد التجنيد |
| Victoria Heart Institute Foundation | Victoria | British Columbia | قيد التجنيد |
| Discovery Clinical Services Ltd | Victoria | British Columbia | قيد التجنيد |
United States
| المنشأة | المدينة | الولاية أو المنطقة | الحالة |
|---|---|---|---|
| Albany Medical College | Albany | New York | قيد التجنيد |
| Advanced Cardiovascular LLC | Alexander City | Alabama | قيد التجنيد |
| PharmaTex Research, LLC | Amarillo | Texas | قيد التجنيد |
يُدرَج 202 موقع إضافي في سجل السجل.
مستندات الدراسة
لا تُرتبط أي مستندات في سجل السجل هذا.
التغيّرات عبر الزمن
- 13 أغسطس 2026
أُضيف موقع
1 site added (252 total)
251252
- 7 أغسطس 2026
أُضيف موقع
2 sites added (251 total)
249251