Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial
Sponsor
Amgen (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05581303
Collaborator
(none)
6,000
84
2
48.1
71.4
1.5
Study Details
Study Description
Brief Summary
The primary objective of this study is to compare the effect of treatment with olpasiran, to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants with atherosclerotic cardiovascular disease (ASCVD) and elevated Lipoprotein(a).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
6000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Olpasiran on Major Cardiovascular Events in Participants With Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein(a)
Actual Study Start Date
:
Dec 14, 2022
Anticipated Primary Completion Date
:
Dec 16, 2026
Anticipated Study Completion Date
:
Dec 16, 2026
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Placebo will be administered by subcutaneous injection, plus standard of care. |
Drug: Placebo
Placebo given by subcutaneous injection once every 12 weeks (Q12W).
|
| Experimental: Olpasiran Olpasiran will be administered by subcutaneous injection, plus standard of care. |
Drug: Olpasiran
Olpasiran given by subcutaneous injection once every 12 weeks (Q12W).
|
Outcome Measures
Primary Outcome Measures
- Time to CHD death, myocardial infarction, or urgent coronary revascularization, whichever occurs first [Approximately 4 years]
Secondary Outcome Measures
- Time to cardiovascular death, myocardial infarction, or ischemic stroke, whichever occurs first [Approximately 4 years]
- Time to cardiovascular death, myocardial infarction, urgent coronary revascularization, or ischemic stroke, whichever occurs first [Approximately 4 years]
- Percent change from baseline to Week 48 in Lipoprotein(a) [Baseline and Week 48]
- Time to myocardial infarction [Approximately 4 years]
- Time to CHD death or myocardial infarction, whichever occurs first [Approximately 4 years]
- Time to urgent coronary revascularization [Approximately 4 years]
- Time to coronary revascularization [Approximately 4 years]
- Time to CHD death [Approximately 4 years]
- Time to cardiovascular death [Approximately 4 years]
- Time to death by any cause [Approximately 4 years]
- Time to ischemic stroke [Approximately 4 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Age 18 to ≤ 85 years
-
Lp(a) ≥ 200 nmol/L during screening
-
History of ASCVD as evidenced by history of either:
-
Myocardial infarction and/or
-
Coronary revascularization with percutaneous coronary intervention with stenting AND at least 1 additional risk factor
Exclusion Criteria:
-
Severe renal dysfunction
-
Active liver disease, known hepatitis, or hepatic dysfunction
-
History of hemorrhagic stroke
-
History of major bleeding disorder
-
Planned cardiac surgery or arterial revascularization
-
Severe heart failure
-
Current, recent, or planned lipoprotein apheresis
-
Previously received ribonucleic acid therapy specifically targeting Lp(a)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Heart Center Research LLC | Huntsville | Alabama | United States | 35801 |
| 2 | Mobile Heart Specialists PC | Mobile | Alabama | United States | 36608 |
| 3 | Alaska Cardiovascular Research Foundation | Anchorage | Alaska | United States | 99508 |
| 4 | Elite Clinical Studies LLC | Phoenix | Arizona | United States | 85018 |
| 5 | Vitality Clinical Research | Beverly Hills | California | United States | 90211 |
| 6 | Westside Medical Associates of Los Angeles | Beverly Hills | California | United States | 90211 |
| 7 | Med Partners, Inc dba Premiere Medical Center, Inc | Toluca Lake | California | United States | 91602 |
| 8 | Cardiology Associates of Fairfield County PC | Stamford | Connecticut | United States | 06905 |
| 9 | Excel Medical Clinical Trials | Boca Raton | Florida | United States | 33434 |
| 10 | Clearwater Cardiovascular Consultants | Clearwater | Florida | United States | 33756 |
| 11 | Cardiology Associates Research LLC | Daytona Beach | Florida | United States | 32117 |
| 12 | Jellinger and Lerman MD PA dba The Center for Diabetes and Endocrine Care | Fort Lauderdale | Florida | United States | 33312 |
| 13 | Westside Center for Clinical Research | Jacksonville | Florida | United States | 32205 |
| 14 | Jacksonville Center for Clinical Research | Jacksonville | Florida | United States | 32216 |
| 15 | Advanced Research for Health Improvement, LLC | Naples | Florida | United States | 34102 |
| 16 | Ocala Cardiovascular Research | Ocala | Florida | United States | 34471 |
| 17 | Saint Johns Center for Clinical Research | Saint Augustine | Florida | United States | 32086 |
| 18 | Northeast Georgia Medical Center Wisteria Building | Gainesville | Georgia | United States | 30501 |
| 19 | NSC Research | Johns Creek | Georgia | United States | 30024 |
| 20 | St Lukes Idaho Cardiology Associates | Meridian | Idaho | United States | 83642 |
| 21 | Northwest Heart Clinical Research LLC | Arlington Heights | Illinois | United States | 60005 |
| 22 | Cardiovascular Research of Northwest Indiana LLC | Munster | Indiana | United States | 46321 |
| 23 | Reid Physician Associates | Richmond | Indiana | United States | 47374 |
| 24 | MercyOne Iowa Heart Center | West Des Moines | Iowa | United States | 50266 |
| 25 | University of Kansas Medical Center | Kansas City | Kansas | United States | 66160 |
| 26 | Midwest Heart and Vascular Specialists | Overland Park | Kansas | United States | 66211 |
| 27 | The Research Group of Lexington LLC | Lexington | Kentucky | United States | 40503 |
| 28 | Louisiana Heart Center | Hammond | Louisiana | United States | 70403 |
| 29 | Clinical Trials of America Inc | Monroe | Louisiana | United States | 71201 |
| 30 | Clinical Trials of America Inc | West Monroe | Louisiana | United States | 71291 |
| 31 | Maryland Cardiovascular Specialists | Baltimore | Maryland | United States | 21229 |
| 32 | Johns Hopkins University School of Medicine | Baltimore | Maryland | United States | 21287 |
| 33 | Metropolitan Cardiovascular Consultants LLC | Beltsville | Maryland | United States | 20705 |
| 34 | TidalHealth Peninsula Regional, Inc | Salisbury | Maryland | United States | 21804 |
| 35 | Care Access - Georgetown | Boston | Massachusetts | United States | 02110 |
| 36 | Care Access - Lake Charles | Boston | Massachusetts | United States | 02110 |
| 37 | Healthy Heart Cardiology | Grand Rapids | Michigan | United States | 49546 |
| 38 | Sparrow Clinical Research Institute | Lansing | Michigan | United States | 48912 |
| 39 | Arcturus Healthcare, PLC, Troy Internal Medicine Research Division | Troy | Michigan | United States | 48098 |
| 40 | Fairview Health Services | Saint Paul | Minnesota | United States | 55102 |
| 41 | Cardiology Associates Research LLC | Tupelo | Mississippi | United States | 38801 |
| 42 | Bryan Heart | Lincoln | Nebraska | United States | 68506 |
| 43 | Palm Research Center Inc | Las Vegas | Nevada | United States | 89128 |
| 44 | Renown Institute for Heart and Vascular Health | Reno | Nevada | United States | 89502 |
| 45 | Icahn School of Medicine at Mount Sinai | New York | New York | United States | 10029 |
| 46 | NY Family Docs | Woodhaven | New York | United States | 11421 |
| 47 | Novant Health Heart and Vascular Institute | Charlotte | North Carolina | United States | 28204 |
| 48 | Cone Health | Greensboro | North Carolina | United States | 27401 |
| 49 | Lillestol Research LLC | Fargo | North Dakota | United States | 58104 |
| 50 | Rama Research LLC | Marion | Ohio | United States | 43302 |
| 51 | Piedmont Research Partners | Fort Mill | South Carolina | United States | 29707 |
| 52 | Monument Health Clinical Research | Rapid City | South Dakota | United States | 57701 |
| 53 | Tennessee Center for Clinical Trials | Tullahoma | Tennessee | United States | 37388 |
| 54 | Texas Diabetes and Endocrinology | Austin | Texas | United States | 78731 |
| 55 | Southwest Family Medicine Associates | Dallas | Texas | United States | 75235 |
| 56 | David Turbay, MD | El Paso | Texas | United States | 79905 |
| 57 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
| 58 | Texas Cardiology Associates of Houston | Kingwood | Texas | United States | 77339 |
| 59 | Texas Institute of Cardiology | McKinney | Texas | United States | 75071 |
| 60 | Permian Research Foundation | Odessa | Texas | United States | 79761 |
| 61 | Virginia Heart | Falls Church | Virginia | United States | 22042 |
| 62 | Carient Heart and Vascular | Manassas | Virginia | United States | 20109 |
| 63 | Royal Prince Alfred Hospital | Camperdown | New South Wales | Australia | 2050 |
| 64 | Concord Repatriation General Hospital | Concord | New South Wales | Australia | 2139 |
| 65 | Holdsworth House Medical Practice | Sydney | New South Wales | Australia | 2010 |
| 66 | GenesisCare Wesley Hospital Auchenflower | Auchenflower | Queensland | Australia | 4066 |
| 67 | GenesisCare Bundaberg Cardiology | Bundaberg | Queensland | Australia | 4670 |
| 68 | Royal Brisbane and Womens Hospital | Herston | Queensland | Australia | 4029 |
| 69 | Nightingale Research | Fullarton | South Australia | Australia | 5063 |
| 70 | GenesisCare Adelaide Cardiology Practice - Leabrook Clinic | Leabrook | South Australia | Australia | 5068 |
| 71 | Royal Hobart Hospital | Hobart | Tasmania | Australia | 7000 |
| 72 | GenesisCare HeartCare Victoria - Berwick | Berwick | Victoria | Australia | 3806 |
| 73 | GenesisCare Ringwood | Bundoora | Victoria | Australia | 3083 |
| 74 | Monash Medical Centre | Clayton | Victoria | Australia | 3168 |
| 75 | Barwon Health Geelong Hospital | Geelong | Victoria | Australia | 3220 |
| 76 | GenesisCare HeartCare Western Australia - Joondalup | Joondalup | Western Australia | Australia | 6027 |
| 77 | Linear Clinical Research Limited | Nedlands | Western Australia | Australia | 6009 |
| 78 | Dr Heart Pty Ltd | Woolloongabba | Australia | 4102 | |
| 79 | Discovery Clinical Services Ltd | Victoria | British Columbia | Canada | V8T 5G4 |
| 80 | LMC Clinical Research Incorporated | Brampton | Ontario | Canada | L6S 0C6 |
| 81 | LMC Clinical Research Incorporated Thornhill | Concord | Ontario | Canada | L4K 4M2 |
| 82 | Ecogene-21 Research | Chicoutimi | Quebec | Canada | G7H 7K9 |
| 83 | Clinique des Maladies Lipidiques de Quebec Incorporated | Quebec | Canada | G1V 4M6 | |
| 84 | Japan Community Health care Organization Kyushu Hospital | Kitakyushu-shi | Fukuoka | Japan | 806-8501 |
Sponsors and Collaborators
- Amgen
Investigators
- Study Director: MD, Amgen
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Amgen
ClinicalTrials.gov Identifier:
NCT05581303
Other Study ID Numbers:
- 20180244
First Posted:
Oct 14, 2022
Last Update Posted:
Feb 2, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Amgen
Additional relevant MeSH terms: