Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Apixaban for the Secondary Prevention of Thromboembolism Among Patients With the AntiphosPholipid Syndrome (ASTRO-APS)

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: NCT02295475
Recruitment Status : Recruiting
First Posted : November 20, 2014
Last Update Posted : February 26, 2019
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Intermountain Health Care, Inc.

Brief Summary:
ASTRO-APS is a prospective, randomized, open-label blinded endpoint pilot study among patients with a clinical diagnosis of the AntiPhospholipid Syndrome and are already taking an anticoagulant for the secondary prevention of thrombosis (blood clots). Subjects will be randomized to receive either warfarin (target INR range 2-3) or apixaban 5 mg twice daily. Patients will follow up with the study team for 13 months. 2 in-clinic follow-up visits will be performed as well as 4 telephone follow-up visits. Study participants will be asked to consent to follow up telephone calls and questionnaires at 3 month intervals following the completion of the study procedures for the main portion of the study.

Condition or disease Intervention/treatment Phase
Antiphospholipid Syndrome Thrombosis Drug: Apixaban Drug: Warfarin Phase 4

Detailed Description:

This pilot study has two primary aims. The first is to identify patients with a clinical diagnosis of APS and then describe their recruitment, enrollment, screening failure rate, adherence to therapy, clinical characteristics, and APS diagnostic criteria in terms of broadly accepted published standards. Essential in this aim is capture of ability to identify, recruit, randomize, and retain patients with APS receiving a direct oral anticoagulant. We will also report compliance and patient satisfaction; central to durable anticoagulation management.

The second aim is to report rates of thrombosis (arterial or venous) and death caused by thrombosis, as well as major bleeding plus clinically relevant non-major bleeding over one year among APS patients randomized to either warfarin or apixaban. As such, we will report the rate of Thrombosis (arterial and/or venous) [ Time Frame: Up to 13 months after enrollment ] [ Designated as safety issue: No ] and Major and non-major bleeding [ Time Frame: Up to 13 months after enrollment ] [ Designated as safety issue: Yes ]


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Apixaban for the Secondary Prevention of Thromboembolism: A Prospective Randomized Outcome Pilot Study Among Patients With the AntiphosPholipid Syndrome
Study Start Date : February 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: Apixaban
Subjects will receive apixaban 5 mg tablets taken twice daily for the duration of the study.
Drug: Apixaban
Study subjects will be randomized to receive Apixaban.

Active Comparator: Warfarin
Subjects will receive warfarin for the duration of the study. The dose and how frequently warfarin is taken depends on the results of the patient's INR blood test(s). The target INR range for this study is 2-3.
Drug: Warfarin
Study subjects will be randomized to receive Warfarin.




Primary Outcome Measures :
  1. Rate of Thrombosis (arterial and/or venous) [ Time Frame: Up to 13 months after enrollment ]
  2. Major and non-major bleeding [ Time Frame: Up to 13 months after enrollment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be ≥ 18 years of age
  2. Have a clinical diagnosis of the APS for which the patient is receiving anticoagulation therapy for the secondary prevention of thrombosis

2.a. Anticoagulation is defined as warfarin sodium titrated at the discretion of the clinician to a target INR 2.5 (range 2-3), 3.0 (range 2.5-3.5), or 3.5 (range 3-4).

2. b. Should the patient be receiving some other form of anticoagulation (apixaban, rivaroxaban, edoxaban, dabigatran etexilate, low-molecular weight heparin) and are willing to be randomized to warfarin with a target INR 2.5 or apixaban 5 mg PO BID and they meet all other inclusion criteria

3. Have completed at least 6months of anticoagulation for the indication of thrombosis and are without acute neurologic symptoms consistent with thrombosis, CVA, or TIA for a minimum of six months.

4. Be willing to provide informed consent to contact the subjects anticoagulation provider for INRs and dosing as well as details regarding any adverse events

5. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.

6. Women must not be breastfeeding

7. Women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug apixaban plus 5 half-lives of study drug apixaban (3 days) plus 30 days (duration of ovulatory cycle) for a total of 33 days post-treatment completion.

8. Males who are sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug apixaban plus 5 half-lives of the study drug apixaban (3 days) plus 90 days (duration of sperm turnover) for a total of 93 days post-treatment completion.

9. Azoospermic males and women of childbearing potential who are continuously not heterosexually active are exempt from contraceptive requirements. However they must still undergo pregnancy testing.

10. Be willing to undergo magnetic resonance imaging (MRI) of the brain

Exclusion Criteria:

  1. Another indication for long-term anticoagulation for which no FDA approval of apixaban exists (e.g. mechanical heart valve)
  2. A life expectancy of less than 1 year
  3. Is unable to attend follow-up appointments
  4. Is participating in a conflicting clinical trial or has participated in a trial within the last 30 days
  5. Is receiving concomitant dual antiplatelet therapy
  6. Requires aspirin dose of greater than 165mg daily
  7. A hemoglobin level of less than 8 mg per deciliter
  8. A platelet count of less than 50,000 per cubic millimeter
  9. Serum creatinine level of more than 2.5 mg per deciliter (221 μmol per liter) or a calculated creatinine clearance of less than 25 ml per minute
  10. Alanine aminotransferase or aspartate aminotransferase level greater than 2 times the upper limit of the normal range
  11. A total bilirubin more than 1.5 times the upper limit of the normal range.
  12. Have active cancer for which treatment (chemotherapy/radiation therapy) is being delivered or has been delivered within the last 3 months
  13. Are actively receiving a strong dual inhibitor of CYP3A4 and P-gp, such as:

13.a Ketoconazole 13.b Itraconazole 13.c Ritonavir 13.d clarithromycin

14. Are actively taking a strong dual inducer of CYP3A4 and P-gp, such as: 14.a rifampin 14.b carbamazepine 14.c phenytoin 14.d St. John's wort

15. Intend pregnancy or breastfeeding within the next year

16. Have a known allergy to apixaban, rivaroxaban, or edoxaban

17. Have experienced thrombosis while receiving warfarin at a target INR of 2-3 and have been assigned a higher target INR at the discretion of their clinician.

18. Patients with active pathological bleeding.

19. A history of arterial thromboembolism (e.g., stroke, myocardial infarction or other arterial thrombosis)

20. Requires clopidogrel, tigacrolor, prasugrel, or another P2Y12 inhibitor

21. Have a history of catastrophic APS (CAPS) as defined by clinical routine

22. Have radiographic evidence of prior arterial thrombosis on MRI as defined per clinical routine upon screening MRI

23. At the discretion of the investigator are considered to not be candidates secondary to s a safety concern.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02295475


Contacts
Layout table for location contacts
Contact: Scott C Woller, MD 801-507-3376 Scott.Woller@imail.org
Contact: Valerie Aston, MBA 801-507-4606 Valerie.Aston@imail.org

Locations
Layout table for location information
United States, California
Midtown Clinic Not yet recruiting
Sacramento, California, United States, 95816
Contact: Anjlee Mahajan, MD    916-734-3772    anmahajan@ucdavis.edu   
Principal Investigator: Anjlee Mahajan, MD         
Sub-Investigator: Adam S Giermasz, MD PhD         
Sub-Investigator: Richard H White, MD         
United States, New York
Hospital for Special Surgery Not yet recruiting
New York, New York, United States, 10021
Contact: Doruk Erkan, MD MPH    212-774-2291    erkand@hss.edu   
Contact: JoAnn Vega, BA    212-774-2795    vegaj@hss.edu   
Principal Investigator: Doruk Erkan, MD MPH         
Sub-Investigator: JoAnn Vega, BA         
United States, North Carolina
Duke University Medical Center Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Thomas L Ortel, MD PhD    919-684-5350    ortel001@mc.duke.edu   
Principal Investigator: Thomas L Ortel, MD PhD         
Sub-Investigator: Gowthami M Arepally, MD         
Sub-Investigator: Ara D Metjian, MD         
United States, Ohio
The James Comprehensive Cancer Center Not yet recruiting
Columbus, Ohio, United States, 43210
Contact: Tzu-Fei Wang, MD    614-293-2887    Tzu-Fei.Wang@osumc.edu   
Principal Investigator: Tzu-Fei Wang, MD         
Sub-Investigator: Eric H Kraut, MD         
Sub-Investigator: Spero R Cataland, MD         
Sub-Investigator: Camila M Castanon, MD         
United States, Utah
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84107
Contact: Valerie Aston, MBA    801-507-4606    Valerie.Aston@imail.org   
Contact: David Tomer, MS    801-507-4694    David.Tomer@imail.org   
Sub-Investigator: David W Branch, MD         
Sub-Investigator: Charles G Elliott, MD         
Sub-Investigator: Scott M Stevens, MD         
Principal Investigator: Scott C Woller, MD         
United States, Wisconsin
BloodCenter of Wisconsin Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Lisa M Baumann Kreuziger, MD MS    414-937-6826    lisa.baumannkreuziger@bcw.edu   
Principal Investigator: Lisa M Baumann Kreuziger, MD MS         
Sub-Investigator: Joshua J Field, MD MS         
Sub-Investigator: Kenneth D Friedman, MD         
Sub-Investigator: Lynn M Malec, MD MSc         
Sub-Investigator: Juliana Perez Botero, MD         
Sub-Investigator: Patrick C Foy, MD         
Sub-Investigator: Kathryn L Koch, APNP         
Sub-Investigator: Ann M Carlin, APNP         
Sub-Investigator: Katrina M Shay, APNP         
Sponsors and Collaborators
Intermountain Health Care, Inc.
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Principal Investigator: Scott C Woller, MD Intermountain Health Care, Inc.

Publications:

Layout table for additonal information
Responsible Party: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT02295475     History of Changes
Other Study ID Numbers: CV185-357
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Syndrome
Antiphospholipid Syndrome
Thrombosis
Thromboembolism
Disease
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Autoimmune Diseases
Immune System Diseases
Warfarin
Apixaban
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action