Trial · NCT03594045
Efficacy and Safety of Apixaban in the Treatment of Heparin Induced Thrombocytopenia (HIT)
NCT03594045, Phase 2, Terminated, Massachusetts General Hospital; results first posted 2020-12-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Apixaban in the Treatment of Heparin Induced Thrombocytopenia (HIT). Trials, record NCT03594045. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03594045
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Apixaban in the Treatment of Heparin Induced Thrombocytopenia (HIT)
- NCT number
- NCT03594045
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Heparin-induced Thrombocytopenia, Heparin-induced Thrombocytopenia and Thrombosis
- Interventions
- Apixaban
- First posted
- 2018-07-20
- Last updated
- 2020-12-23
- Results first posted
- 2020-12-23
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cumulative Incidence of New Symptomatic Thromboembolic Complications (TEC) Within 30 Days of the Initiation of Apixaban | 30 days | New TEC |
| Secondary | 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 |
| Secondary | 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 | Composite cumulative incidence |
| Secondary | 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 | Major Bleeding |
| Secondary | 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 | The time to platelet recovery serves as a surrogate index of the activity of apixaban. |
| Secondary | 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 | Death due to any cause during treatment or the follow-up period following treatment. |
| Secondary | Cumulative Incidence of Limb Amputation | 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 | |
| Secondary | Cumulative Incidence of New Thromboembolic Complications (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 | New TEC during the study. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cumulative Incidence of New Symptomatic Thromboembolic Complications (TEC) Within 30 Days of the Initiation of Apixaban | 30 days | No HIT patients were enrolled | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | No HIT patients were enrolled | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | No HIT patients were enrolled | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | No HIT patients were enrolled | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | No HIT patients were enrolled | Days | MEDIAN |
| SECONDARY | 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 | No HIT patients were enrolled | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cumulative Incidence of Limb Amputation | 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 | No HIT patients were enrolled | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cumulative Incidence of New Thromboembolic Complications (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 | No HIT patients were enrolled | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cumulative Incidence of New Symptomatic Thromboembolic Complications (TEC) Within 30 Days of the Initiation of Apixaban | Apixaban for HITT | 0 | Participants | ||
| Composite Cumulative Incidence of All-cause Mortality, Limb Amputation and New TEC | Apixaban for HITT | 0 | Participants | ||
| Composite Cumulative Incidence of New TEC and Major Bleeding | Apixaban for HITT | 0 | Participants | ||
| Cumulative Incidence of Major Bleeding | Apixaban for HITT | 0 | Participants | ||
| Time to Platelet Recovery | Apixaban for HITT | 2 | Full Range 2 to 5 | Days | |
| Cumulative Incidence of All Cause Mortality | Apixaban for HITT | 0 | Participants | ||
| Cumulative Incidence of Limb Amputation | Apixaban for HITT | 0 | Participants | ||
| Cumulative Incidence of New Thromboembolic Complications (TEC) | Apixaban for HITT | 0 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Apixaban for HIT | 0 | |
| Overall Study | STARTED | Apixaban for HITT | 5 | |
| Overall Study | COMPLETED | Apixaban for HIT | 0 | |
| Overall Study | COMPLETED | Apixaban for HITT | 5 | |
| Overall Study | NOT COMPLETED | Apixaban for HIT | 0 | |
| Overall Study | NOT COMPLETED | Apixaban for HITT | 0 |
Source ClinicalTrials.gov
Adverse events40
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bruising | Injury, poisoning and procedural complications | Apixaban for HIT | 0 | 0 | 0 |
| other | Bruising | Injury, poisoning and procedural complications | Apixaban for HITT | 1 | 5 | 3 |
| other | Dizziness | Nervous system disorders | Apixaban for HIT | 0 | 0 | 0 |
| other | Dizziness | Nervous system disorders | Apixaban for HITT | 1 | 5 | 5 |
| other | Dry skin | Skin and subcutaneous tissue disorders | Apixaban for HIT | 0 | 0 | 0 |
| other | Dry skin | Skin and subcutaneous tissue disorders | Apixaban for HITT | 1 | 5 | 2 |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Apixaban for HIT | 0 | 0 | 0 |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Apixaban for HITT | 1 | 5 | 2 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Apixaban for HIT | 0 | 0 | 0 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Apixaban for HITT | 1 | 5 | 5 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Apixaban for HIT | 0 | 0 |
| Total, all-cause mortality | Apixaban for HITT | 0 | 5 |
| Total, other adverse events | Apixaban for HIT | 0 | 0 |
| Total, other adverse events | Apixaban for HITT | 4 | 5 |
| Total, serious adverse events | Apixaban for HIT | 0 | 0 |
| Total, serious adverse events | Apixaban for HITT | 0 | 5 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03594045
GET https://conductscience.org/api/trials/v1/NCT03594045/events?page=2