Stroke Clinical Trial
— AZALEA-TIMI 71Official title:
A Multicenter, RandomiZed, Active-ControLled Study to Evaluate the Safety and Tolerability of Two Blinded Doses of Abelacimab (MAA868) Compared With Open-Label Rivaroxaban in Patients With Atrial Fibrillation (AZALEA)
| Verified date | June 2024 |
| Source | Anthos Therapeutics, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of the ANT-006 study is to evaluate the bleeding profile of abelacimab relative to rivaroxaban in patients with atrial fibrillation (AF) at moderate-to-high risk of stroke.
| Status | Active, not recruiting |
| Enrollment | 1200 |
| Est. completion date | December 2025 |
| Est. primary completion date | December 14, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 55 Years and older |
| Eligibility | Inclusion Criteria: - Male and female patients = 55 years old - Patients with a history of atrial fibrillation (AF) or atrial flutter with planned indefinite anticoagulation - Patients with a CHA2DS2-VASc of =4 OR a CHA2DS2-VASc of =3 with at least 1 of the following: 1. Planned concomitant use of antiplatelet medication use (i.e., aspirin and/or P2Y12 inhibitor) for the duration of the trial 2. Creatinine Clearance (CrCl) =50 ml/min by the Cockcroft-Gault equation Exclusion Criteria: - History of hypersensitivity to any of the study drugs (including rivaroxaban) or its excipients, to drugs of similar chemical classes, or any contraindication listed in the label for rivaroxaban - Patients with an intracranial or intraocular bleed within the 3 months prior to screening - Clinically significant mitral stenosis (valve area <1.5 cm2) - Mechanical heart valve or other indication for anticoagulation therapy other than atrial fibrillation (e.g., venous thromboembolism) - Known presence of an atrial myxoma or left ventricular thrombus - History of left atrial appendage closure or removal - Active endocarditis Other protocol defined Inclusion/Exclusion criteria may apply |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Anthos Investigative Site | Cambridge | Ontario |
| Canada | Anthos Investigative Site | Greenfield Park | Quebec |
| Canada | Anthos Investigative Site | Montréal | Quebec |
| Canada | Anthos Investigative Site | Oshawa | Ontario |
| Canada | Anthos Investigative Site | Sudbury | Ontario |
| Czechia | Anthos Investigative Site | Brandýs Nad Labem | Stredoceský Kraj |
| Czechia | Anthos Investigative Site | Ceská Lípa | LI |
| Czechia | Anthos Investigative Site | Holešov | Zlín |
| Czechia | Anthos Investigative Site | Kromeríž | ZL |
| Czechia | Anthos Investigative Site | Liberec | LB |
| Czechia | Anthos Investigative Site | Liberec | LI |
| Czechia | Anthos Investigative Site | Mariánské Lázne | KA |
| Czechia | Anthos Investigative Site | Pardubice | PA |
| Czechia | Anthos Investigative Site | Podebrady | Stredoceský Kraj |
| Czechia | Anthos Investigative Site | Praha | PR |
| Czechia | Anthos Investigative Site | Praha | PR |
| Czechia | Anthos Investigative Site | Praha | PR |
| Czechia | Anthos Investigative Site | Príbram | Stredoceský Kraj |
| Czechia | Anthos Investigative Site | Slaný | Stredoceský Kraj |
| Czechia | Anthos Investigative Site | Trutnov | KR |
| Hungary | Anthos Investigative Site | Baja | BK |
| Hungary | Anthos Investigative Site | Balatonfüred | VE |
| Hungary | Anthos Investigative Site | Balatonfüred | VM |
| Hungary | Anthos Investigative Site | Budapest | BP |
| Hungary | Anthos Investigative Site | Budapest | BP |
| Hungary | Anthos Investigative Site | Budapest | BU |
| Hungary | Anthos Investigative Site | Budapest | BU |
| Hungary | Anthos Investigative Site | Debrecen | HB |
| Hungary | Anthos Investigative Site | Kaposvár | SO |
| Hungary | Anthos Investigative Site (4002) | Nyíregyháza | SZ |
| Hungary | Anthos Investigative Site (4003) | Nyíregyháza | SZ |
| Hungary | Anthos Investigative Site | Orosháza | BE |
| Hungary | Anthos Investigative Site | Székesfehérvár | FE |
| Korea, Republic of | Anthos Investigative Site | Seogu | Busan |
| Korea, Republic of | Anthos Investigative Site | Seongnam-si | Gyeonggi |
| Korea, Republic of | Anthos Investigative Site | Seongnam-si | Gyeonggi |
| Korea, Republic of | Anthos Investigative Site | Seoul | |
| Korea, Republic of | Anthos Investigative Site | Seoul | |
| Korea, Republic of | Anthos Investigative Site | Seoul | |
| Poland | Anthos Investigative Site | Bielsko-Biala | SL |
| Poland | Anthos Investigative Site | Chrzanów | MA |
| Poland | Anthos Investigative Site | Dabrowa Górnicza | SL |
| Poland | Anthos Investigative Site | Elblag | WN |
| Poland | Anthos Investigative Site | Gdynia | PM |
| Poland | Anthos Investigative Site | Gdynia | GDY |
| Poland | Anthos Investigative Site | Kraków | MA |
| Poland | Anthos Investigative Site | Lódz | LD |
| Poland | Anthos Investigative Site | Lublin | LU |
| Poland | Anthos Investigative Site | Plock | MZ |
| Poland | Anthos Investigative Site | Przemysl | PK |
| Poland | Anthos Investigative Site | Ruda Slaska | SL |
| Poland | Anthos Investigative Site | Tychy | SL |
| Poland | Anthos Investigative Site | Warsaw | MZ |
| Poland | Anthos Investigative Site | Warszawa | MZ |
| Poland | Anthos Investigative Site | Wroclaw | DS |
| Poland | Anthos Investigative Site | Zamosc | LB |
| Poland | Anthos Investigative Site | Zarów | DS |
| Taiwan | Anthos Investigative Site | Hualien City | HUA |
| Taiwan | Anthos Investigative Site | Kaohsiung | KHH |
| Taiwan | Anthos Investigative Site | Taipei | HSZ |
| Taiwan | Anthos Investigative Site | Taipei | TPE |
| Taiwan | Anthos Investigative Site | Taipei City | TPE |
| Taiwan | Anthos Investigative Site | Tiachung | TXG |
| Taiwan | Anthos Investigative Site | Yilan | ILA |
| United States | Anthos Investigative Site | Baltimore | Maryland |
| United States | Anthos Investigative Site | Camp Hill | Pennsylvania |
| United States | Anthos Investigative Site | Clearwater | Florida |
| United States | Anthos Investigative Site | Daytona Beach | Florida |
| United States | Anthos Investigative Site | Falls Church | Virginia |
| United States | Anthos Investigative Site | Fargo | North Dakota |
| United States | Anthos Investigative Site | Framingham | Massachusetts |
| United States | Anthos Investigative Site | Haverhill | Massachusetts |
| United States | Anthos Investigative Site | Huntsville | Alabama |
| United States | Anthos Investigative Site | Johns Creek | Georgia |
| United States | Anthos Investigative Site | Kingsport | Tennessee |
| United States | Anthos Investigative Site | Kingwood | Texas |
| United States | Anthos Investigative Site | Lansing | Michigan |
| United States | Anthos Investigative Site | Largo | Florida |
| United States | Anthos Investigative Site | Lenoir | North Carolina |
| United States | Anthos Investigative Site | Manassas | Virginia |
| United States | Anthos Investigative Site | Mobile | Alabama |
| United States | Anthos Investigative Site | Odessa | Texas |
| United States | Anthos Investigative Site | Oklahoma City | Oklahoma |
| United States | Anthos Investigative Site | Owensboro | Kentucky |
| United States | Anthos Investigative Site | Poughkeepsie | New York |
| United States | Anthos Investigative Site | Safety Harbor | Florida |
| United States | Anthos Investigative Site | Saint Augustine | Florida |
| United States | Anthos Investigative Site | Salisbury | Maryland |
| United States | Anthos Investigative Site | Sewell | New Jersey |
| United States | Anthos Investigative Site | Southampton | New York |
| United States | Anthos Investigative Site | Stamford | Connecticut |
| United States | Anthos Investigative Site | Tomball | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Anthos Therapeutics, Inc. | Fortrea, The TIMI Study Group |
United States, Canada, Czechia, Hungary, Korea, Republic of, Poland, Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluate effect of abelacimab relative to rivaroxaban on the rate of major or clinically relevant non-major (CRNM) bleeding events | Time to first event of composite of International Society on Thrombosis and Haemostasis (ISTH)-defined major bleeding or CRNM bleeding events | From randomization through study completion, an average of 17 months | |
| Secondary | Evaluate effect of abelacimab relative to rivaroxaban on the rate of major bleeding events | Time to first event ISTH-defined major bleeding events | From randomization through study completion, an average of 17 months | |
| Secondary | Evaluate the effect of abelacimab relative to rivaroxaban on the rate of major or minor bleeding events | Time to first event ISTH-defined major or minor bleeding events | From randomization through study completion, an average of 17 months |
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