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Anticoagulant

Apixaban for HITT for HIT syndrome

Phase 2

Waitlist Available

Led By Rachel P Rosovsky, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

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.

Eligible Conditions

HIT syndrome
Heparin Induced Thrombocytopenia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Composite Cumulative Incidence of New TEC and Major Bleeding

Cumulative Incidence of All Cause Mortality

+3 more

Side effects data

From 2018 Phase 4 trial • 557 Patients • NCT01884337

Incision site pain

100%

80%

60%

40%

20%

Study treatment Arm

TOTAL KNEE REPLACEMENT (TKR)

TOTAL HIP REPLACEMENT (THR)

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Apixaban for HITTExperimental Treatment1 Intervention

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.

Group II: Apixaban for HITExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Apixaban

FDA approved

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