CLINICAL TRIALS PROFILE FOR APIXABAN
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505(b)(2) Clinical Trials for Apixaban
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| OTC | NCT04550338 ↗ | Antiviral Effects of TXA as a Preventative Treatment Following COVID-19 Exposure | Withdrawn | University of Alabama at Birmingham | Phase 3 | 2021-08-01 | A recent report in Physiolological Reviews proposed that the endogenous protease plasmin acts on SARS-CoV-2 by cleaving a newly inserted furin site in the S protein portion of the virus resulting in increased infectivity and virulence. A logical treatment that might blunt this process would be the inhibition of the conversion of plasminogen to plasmin. Fortunately, there is an inexpensive, commonly used drug, tranexamic acid, TXA, which suppresses this conversion and could be re-purposed for the treatment of COVID-19. TXA is a synthetic analog of the amino acid lysine which reversibly binds four to five lysine receptor sites on plasminogen. This reduces conversion of plasminogen to plasmin, and is normally used to prevent fibrin degradation. TXA is FDA approved for the outpatient treatment of heavy menstrual bleeding (typical dose 1300 mg p.o. TID x 5 days) and off-label use for many other indications. TXA is used perioperatively as a standard-of-care at UAB for orthopedic and cardiac bypass surgeries. It has a long track record of safety such that it is used over-the-counter in other countries as an antiviral and for the treatment of cosmetic dermatological disorders. Given the potential benefit and limited toxicity of TXA it would appear warranted to perform randomized, double-blind placebo controlled exploratory trial at UAB as a prophylactic antiviral treatment following exposure to COVID-19 in order to determine whether it reduces infectivity and virulence of the SARS-CoV-2 virus as hypothesized. Involvement of each patient is only for 7 days before primary endpoints and 30 days for final data collection. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for Apixaban
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00097357 ↗ | BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery | Completed | Bristol-Myers Squibb | Phase 2/Phase 3 | 2004-10-01 | The purpose of this study is to learn if BMS-562247 can prevent blood clots in the legs and lungs in men and women following unilateral total knee replacement surgery. The safety of this treatment will also be studied. |
| NCT00252005 ↗ | Oral Direct Factor Xa-inhibitor Apixaban in Patients With Acute Symptomatic Deep-vein Thrombosis-The Botticelli DVT Study | Completed | Bristol-Myers Squibb | Phase 2 | 2005-11-01 | The purpose of this clinical research study is to assess efficacy and safety of 3 doses of apixaban 5 mg twice a day, 10 mg twice a day and 20 mg once daily versus conventional treatment with low molecular weight heparin or fondaparinux and vitamin K antagonist in the treatment of subjects with acute symptomatic deep-vein thrombosis. |
| NCT00313300 ↗ | Safety Study of Apixaban in Recent Acute Coronary Syndrome | Completed | Bristol-Myers Squibb | Phase 2 | 2006-05-01 | The purpose of this clinical research study is to determine whether apixaban will be safe in people who have recently had unstable angina or a heart attack. |
| NCT00320255 ↗ | A Phase 2 Pilot Study of Apixaban for the Prevention of Thromboembolic Events in Patients With Advanced (Metastatic) Cancer | Completed | Ontario Clinical Oncology Group (OCOG) | Phase 2 | 2006-06-01 | The purpose of this study is to learn whether apixaban is well-tolerated and acceptable as anticoagulant therapy, when administered to patients with advanced or metastatic cancer and at increased risk for venous thromboembolic events. Demonstration of a favorable benefit:risk profile could lead to significant reduction in this serious and sometimes fatal complication of ongoing cancer and its treatment. |
| NCT00320255 ↗ | A Phase 2 Pilot Study of Apixaban for the Prevention of Thromboembolic Events in Patients With Advanced (Metastatic) Cancer | Completed | Bristol-Myers Squibb | Phase 2 | 2006-06-01 | The purpose of this study is to learn whether apixaban is well-tolerated and acceptable as anticoagulant therapy, when administered to patients with advanced or metastatic cancer and at increased risk for venous thromboembolic events. Demonstration of a favorable benefit:risk profile could lead to significant reduction in this serious and sometimes fatal complication of ongoing cancer and its treatment. |
| NCT00371683 ↗ | Study of Apixaban for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery | Completed | Bristol-Myers Squibb | Phase 3 | 2006-11-01 | The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein Thrombosis [DVT]) and lung (pulmonary embolism [PE]) that sometimes occur after knee replacement surgery and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied. |
| NCT00412984 ↗ | Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation | Completed | Bristol-Myers Squibb | Phase 3 | 2006-12-31 | The trial seeks to determine if apixaban, an investigational anticoagulant (blood-thinner) is as effective as standard therapy (warfarin) in preventing stroke and systemic embolism in subjects with atrial fibrillation and risk factors for stroke. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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