Calf Deep Vein Thrombosis Treatment Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03590743|
Recruitment Status : Recruiting
First Posted : July 18, 2018
Last Update Posted : March 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Deep Vein Thrombosis||Drug: Apixaban Other: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Multicenter, randomized, double blind, placebo-controlled, superiority clinical trial.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Double blind, placebo controlled|
|Official Title:||A Phase IV, Randomized, Double Blind Study Evaluating the Safety and Efficacy of Apixaban in Subjects With Calf Vein Thrombosis|
|Actual Study Start Date :||February 19, 2019|
|Estimated Primary Completion Date :||August 15, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Active Comparator: Apixaban
Apixaban 5mg (10 mg twice daily for 7 days followed by 5 mg twice daily for 3 months).
Active anticoagulation with apixaban 10 mg twice daily for 7 days followed by 5 mg twice daily to complete a total of 3 months treatment.
Other Name: Eliquis
Placebo Comparator: Placebo
Patients will receive matching placebo.
apixaban matching placebo 2 tablets twice daily for 7 days followed by one tablet twice daily to complete a total of 3 months.
- Number of subjects who experience a composite venous thromboembolism (VTE) event within 3 months [ Time Frame: Within 3 months of therapy initiation ]The composite VTE event will include thrombus propagation either within the calf veins or into proximal deep veins (popliteal, femoral or iliac veins), symptomatic or incidental VTE recurrence or all-cause mortality within 3 months of therapy initiation. All suspected VTE events will be evaluated by a central, blinded, independent adjudication committee.
- Number of subjects who experience either major bleeding or clinically relevant non-major bleeding within 3 months [ Time Frame: Within 3 months of therapy initiation ]
Major bleeding is defined as overt bleeding plus a hemoglobin decrease of ≥ 2 g/dL or transfusion of ≥ 2 units of packed red blood cells, or bleeding at a critical site: intracranial, intraspinal, intraocular, retroperitoneal, pericardial intra-articular, intramuscular with compartment syndrome, or fatal bleeding.
Clinically relevant non-major bleeding is defined as any overt, actionable sign of hemorrhage meeting at least one of the following criteria: (i) requiring nonsurgical, medical intervention by a healthcare professional, (ii) leading to hospitalization or increased level of care, or (iii) prompting evaluation.
All patients who received at least one dose of study medication will be included in the safety analysis. All suspected bleeding events will be evaluated by a central, blinded, independent adjudication committee.
- Mean Time of Thrombus Propagation [ Time Frame: Within 3 months of therapy initiation ]The timing of thrombus propagation for those individuals who have suffered such an event. The date of thrombus propagation confirmation will be compared to the date of the original DVT diagnosis for this purpose.
- Net Clinical Benefit or Harm for the Two Strategies [ Time Frame: Within 3 months of therapy initiation. ]The outcome of net clinical benefit or harm will be assessed as the composite of the primary efficacy outcome or the principal safety outcome up to day 90. The difference in the incidences of the combined endpoint at 3 months between treatment arms will be estimated and tested using a normal approximation of the binomial distribution. All tests will be conducted at the two-sided 0.05 significance level.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03590743
|Contact: Dawn Shelstadfirstname.lastname@example.org|
|Contact: Trevor Stromme||507-293-2754||Stromme.Trevor@mayo.edu|
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|United States, Wisconsin|
|Eau Claire, Wisconsin, United States, 54701|
|Contact: Andrew Calvin, MD 715-838-6836 email@example.com|
|Contact: Holly Hennlich 715-464-8172 firstname.lastname@example.org|
|La Crosse, Wisconsin, United States, 54601|
|Contact: Carolyn R Flock 608-392-9462 Flock.Carolyn@mayo.edu|
|Contact: Patsy Cacerers Figueroa 608-392-9280 email@example.com|
|Principal Investigator:||Robert D McBane||Mayo Clinic|