Trial Outcomes & Findings for Efficacy and Safety of Apixaban in the Treatment of Heparin Induced Thrombocytopenia (HIT) (NCT NCT03594045)

NCT ID: NCT03594045

Last Updated: 2020-12-23

Results Overview

New TEC

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2020-12-23

Participant Flow

Participant milestones

Measure	Apixaban for HIT 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. Apixaban: Apixaban is an anticoagulant that works by inhibiting the coagulation factor, Factor Xa.	Apixaban for HITT 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. Apixaban: Apixaban is an anticoagulant that works by inhibiting the coagulation factor, Factor Xa.
Overall Study STARTED	0	5
Overall Study COMPLETED	0	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Apixaban for HIT 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. Apixaban: Apixaban is an anticoagulant that works by inhibiting the coagulation factor, Factor Xa.	Apixaban for HITT n=5 Participants 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. Apixaban: Apixaban is an anticoagulant that works by inhibiting the coagulation factor, Factor Xa.	Total n=5 Participants Total of all reporting groups
Age, Continuous	—	68 years n=5 Participants	68 years n=5 Participants
Sex: Female, Male Female	—	2 Participants n=5 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	—	3 Participants n=5 Participants	3 Participants n=5 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	—	5 participants n=5 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: No HIT patients were enrolled

New TEC

Outcome measures

Measure	Apixaban for HIT 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. Apixaban: Apixaban is an anticoagulant that works by inhibiting the coagulation factor, Factor Xa.	Apixaban for HITT n=5 Participants 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. Apixaban: Apixaban is an anticoagulant that works by inhibiting the coagulation factor, Factor Xa.
Cumulative Incidence of New Symptomatic Thromboembolic Complications (TEC) Within 30 Days of the Initiation of Apixaban	—	0 Participants

SECONDARY outcome

Timeframe: 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

Population: No HIT patients were enrolled

Composite cumulative incidence

Outcome measures

Measure	Apixaban for HIT 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. Apixaban: Apixaban is an anticoagulant that works by inhibiting the coagulation factor, Factor Xa.	Apixaban for HITT n=5 Participants 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. Apixaban: Apixaban is an anticoagulant that works by inhibiting the coagulation factor, Factor Xa.
Composite Cumulative Incidence of All-cause Mortality, Limb Amputation and New TEC	—	0 Participants

SECONDARY outcome

Timeframe: 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

Population: No HIT patients were enrolled

Composite cumulative incidence

Outcome measures

Measure	Apixaban for HIT 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. Apixaban: Apixaban is an anticoagulant that works by inhibiting the coagulation factor, Factor Xa.	Apixaban for HITT n=5 Participants 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. Apixaban: Apixaban is an anticoagulant that works by inhibiting the coagulation factor, Factor Xa.
Composite Cumulative Incidence of New TEC and Major Bleeding	—	0 Participants

SECONDARY outcome

Timeframe: 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

Population: No HIT patients were enrolled

Major Bleeding

Outcome measures

Measure	Apixaban for HIT 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. Apixaban: Apixaban is an anticoagulant that works by inhibiting the coagulation factor, Factor Xa.	Apixaban for HITT n=5 Participants 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. Apixaban: Apixaban is an anticoagulant that works by inhibiting the coagulation factor, Factor Xa.
Cumulative Incidence of Major Bleeding	—	0 Participants

SECONDARY outcome

Timeframe: 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

Population: No HIT patients were enrolled

The time to platelet recovery serves as a surrogate index of the activity of apixaban.

Outcome measures

Measure	Apixaban for HIT 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. Apixaban: Apixaban is an anticoagulant that works by inhibiting the coagulation factor, Factor Xa.	Apixaban for HITT n=5 Participants 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. Apixaban: Apixaban is an anticoagulant that works by inhibiting the coagulation factor, Factor Xa.
Time to Platelet Recovery	—	2 Days Interval 2.0 to 5.0

SECONDARY outcome

Timeframe: 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

Population: No HIT patients were enrolled

Death due to any cause during treatment or the follow-up period following treatment.

Outcome measures

Measure	Apixaban for HIT 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. Apixaban: Apixaban is an anticoagulant that works by inhibiting the coagulation factor, Factor Xa.	Apixaban for HITT n=5 Participants 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. Apixaban: Apixaban is an anticoagulant that works by inhibiting the coagulation factor, Factor Xa.
Cumulative Incidence of All Cause Mortality	—	0 Participants

SECONDARY outcome

Timeframe: 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

Population: No HIT patients were enrolled

Outcome measures

Measure	Apixaban for HIT 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. Apixaban: Apixaban is an anticoagulant that works by inhibiting the coagulation factor, Factor Xa.	Apixaban for HITT n=5 Participants 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. Apixaban: Apixaban is an anticoagulant that works by inhibiting the coagulation factor, Factor Xa.
Cumulative Incidence of Limb Amputation	—	0 Participants

SECONDARY outcome

Timeframe: 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

Population: No HIT patients were enrolled

New TEC during the study.

Outcome measures

Measure	Apixaban for HIT 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. Apixaban: Apixaban is an anticoagulant that works by inhibiting the coagulation factor, Factor Xa.	Apixaban for HITT n=5 Participants 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. Apixaban: Apixaban is an anticoagulant that works by inhibiting the coagulation factor, Factor Xa.
Cumulative Incidence of New Thromboembolic Complications (TEC)	—	0 Participants

Adverse Events

Apixaban for HIT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Apixaban for HITT

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Apixaban for HIT 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. Apixaban: Apixaban is an anticoagulant that works by inhibiting the coagulation factor, Factor Xa.	Apixaban for HITT n=5 participants at risk 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. Apixaban: Apixaban is an anticoagulant that works by inhibiting the coagulation factor, Factor Xa.
Injury, poisoning and procedural complications Bruising	— 0/0 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled	20.0% 1/5 • Number of events 3 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled
Nervous system disorders Dizziness	— 0/0 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled	20.0% 1/5 • Number of events 5 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled
Skin and subcutaneous tissue disorders Dry skin	— 0/0 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled	20.0% 1/5 • Number of events 2 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled
Respiratory, thoracic and mediastinal disorders Dyspnea	— 0/0 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled	20.0% 1/5 • Number of events 2 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled
Respiratory, thoracic and mediastinal disorders Epistaxis	— 0/0 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled	20.0% 1/5 • Number of events 5 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled
General disorders Fatigue	— 0/0 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled	20.0% 1/5 • Number of events 3 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled
General disorders Fever	— 0/0 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled	20.0% 1/5 • Number of events 3 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled
Vascular disorders Hematoma	— 0/0 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled	20.0% 1/5 • Number of events 3 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled
Metabolism and nutrition disorders Hypokalemia	— 0/0 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled	20.0% 1/5 • Number of events 3 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled
Psychiatric disorders Insomnia	— 0/0 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled	20.0% 1/5 • Number of events 4 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled
Infections and infestations Lung infection	— 0/0 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled	20.0% 1/5 • Number of events 6 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled
Skin and subcutaneous tissue disorders Nail discoloration	— 0/0 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled	20.0% 1/5 • Number of events 2 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled
General disorders Non-cardiac chest pain	— 0/0 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled	40.0% 2/5 • Number of events 6 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled
General disorders Pain	— 0/0 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled	20.0% 1/5 • Number of events 2 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled
Respiratory, thoracic and mediastinal disorders Respiratory failure	— 0/0 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled	20.0% 1/5 • Number of events 3 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled
Infections and infestations Sepsis	— 0/0 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled	20.0% 1/5 • Number of events 3 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled
Nervous system disorders Tremor	— 0/0 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled	20.0% 1/5 • Number of events 4 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled
Infections and infestations Urinary tract infection	— 0/0 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled	20.0% 1/5 • Number of events 6 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled
Investigations Weight loss	— 0/0 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled	20.0% 1/5 • Number of events 3 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled
Infections and infestations Wound infection	— 0/0 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled	20.0% 1/5 • Number of events 3 • From the start of treatment until 3 days after the last treatment was received, up to approximately 4 months No HIT patients were enrolled

Additional Information

Dr. Rachel Rosovsky

Massachusetts General Hospital

Phone: 617-724-4000

Email: RPROSOVSKY@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place