Efficacy and Safety of Apixaban in the Treatment of Heparin Induced Thrombocytopenia (HIT)

NCT03594045 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 18-153
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

Brief Summary

This research study is studying a drug as a possible treatment for heparin induced thrombocytopenia (HIT) or Heparin-induced Thrombocytopenia and Thrombosis (HITT). The drug involved in this study is apixaban.

Conditions

Heparin-induced Thrombocytopenia; Heparin-induced Thrombocytopenia and Thrombosis

Keywords

Heparin-induced Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• Cumulative Incidence of New Symptomatic Thromboembolic Complications (TEC) Within 30 Days of the Initiation of Apixaban

  New TEC

  30 days

Secondary Outcomes (7)

• Composite Cumulative Incidence of All-cause Mortality, Limb Amputation and New TEC

  From the start of treatment until 30 days after the end of treatment, up to 60 days total for participants with HIT and up to 120 days total for participants with HITT

• Composite Cumulative Incidence of New TEC and Major Bleeding

  From the start of treatment until 30 days after the end of treatment, up to 60 days total for participants with HIT and up to 120 days total for participants with HITT

• Cumulative Incidence of Major Bleeding

  From the start of treatment until 30 days after the end of treatment, up to 60 days total for participants with HIT and up to 120 days total for participants with HITT

• Time to Platelet Recovery

  From the start of treatment until time of platelet recovery, up to 60 days total for participants with HIT and up to 120 days total for participants with HITT

• Cumulative Incidence of All Cause Mortality

  From the start of treatment until the time of death or until 30 days after the end of treatment, up to 60 days total for participants with HIT and up to 120 days total for participants with HITT

Study Arms (2)

Apixaban for HIT

EXPERIMENTAL

Patients with Heparin Induced Thrombocytopenia (HIT) will receive Apixaban, at an initial dose of 10 mg orally twice a day for 7 days followed by 5 mg twice a day for a total of 30 days.

Drug: Apixaban

Apixaban for HITT

EXPERIMENTAL

Patients with Heparin Induced Thrombocytopenia with Thrombosis (HITT) will receive Apixaban, at an initial dose of 10 mg orally twice a day for 7 days followed by 5 mg twice a day for a total of 3 months.

Drug: Apixaban

Interventions

Apixaban DRUG

Apixaban is an anticoagulant that works by inhibiting the coagulation factor, Factor Xa.

Apixaban for HIT; Apixaban for HITT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized patients at MGH and participating Dana Farber/Harvard Cancer Center (DF/HCC) sites.
• Patient must have a diagnosis of HIT or high clinical suspicion of HIT, with a 4 T score of ≥ 5 as calculated by the following criteria:
• Thrombocytopenia
• Platelet count fall \>50 percent and nadir ≥20,000/microL - 2 points
• Platelet count fall 30 to 50 percent or nadir 10 to 19,000/microL - 1 points
• Platelet count fall \<30 percent or nadir \<10,000/microL - 0 points
• Timing of platelet count fall
• Clear onset between days 5 and 10 or platelet count fall at ≤1 day if prior heparin exposure within the last 30 days - 2 points
• Consistent with fall at 5 to 10 days but unclear (eg, missing platelet counts), onset after day 10, or fall ≤1 day with prior heparin exposure within 30 to 100 days - 1 point
• Platelet count fall at \<4 days without recent exposure - 0 points
• Thrombosis or other sequelae
• Confirmed new thrombosis, skin necrosis, or acute systemic reaction after intravenous unfractionated heparin bolus - 2 points
• Progressive or recurrent thrombosis, non-necrotizing (erythematous) skin lesions, or suspected thrombosis that has not been proven - 1 point
• None - 0 points
• Other causes for thrombocytopenia

You may not qualify if:

• Patient requires anticoagulation for a mechanical heart valve.
• Patient requires:
• anticoagulation for another indication for long-term anticoagulation therapy,
• dual antiplatelet therapy,
• treatment with aspirin at a dose of more than 162 mg daily
• Patient has signs of active or ongoing clinically significant hemorrhage.
• Patient has hereditary or acquired coagulopathy or bleeding disorder.
• Patient has a contraindication to apixaban.
• Participants receiving any medications or substances that are inhibitors or inducers of cytochrome P-450 3A4 or p-glycoprotein are ineligible. Because this list of these agents are constantly changing, it is important to regularly consult a frequently-updated list. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product.
• Patient has severe renal insufficiency (CrCl \<25 ml/min-as used in the AMPLIFY trial)
• Patient has hepatic disease (including Child-Pugh B and C) associated with coagulopathy or clinically relevant bleeding risk.
• Recent (previous seven days), or complicated lumbar puncture or epidural catheter placement or removal.
• Patient has high potential need to undergo a surgical or major invasive procedure in the near future.
• Patient has a history of uncorrected cerebral aneurysm, intracranial tumor or hemorrhagic cerebrovascular accident.
• Patient refuses to receive transfused blood products should this intervention become clinically indicated.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Bristol-Myers Squibb: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02214, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Brigham and Women Hospital

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Thrombosis

Interventions

apixaban

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Rachel Rosovsky
• Organization: Massachusetts General Hospital

RPROSOVSKY@mgh.harvard.edu

617-724-4000

Study Officials

• Rachel P Rosovsky, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: July 20, 2018
• Study Start: December 18, 2018
• Primary Completion: October 30, 2019
• Study Completion: October 30, 2019
• Last Updated: December 23, 2020
• Results First Posted: December 23, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)