Acute Coronary SyndromePhase 4H-REPLACENCT03363035
Safety and Efficacy of LMWH Versus Rivaroxaban in Chinese Patients Hospitalized With Acute Coronary Syndrome
A Phase 4 study testing Rivaroxaban 2.5 mg, Rivaroxaban 5 mg and Enoxaparin in people with Acute Coronary Syndrome and Myocardial Infarction, run by Second Xiangya Hospital of Central South University at 24 sites in China.
Trial summary
H-REPLACE trial is a prospective, randomized, open-label, active-controlled, multicenter study in participants with ACS (STEMI or NSTEMI, unstable angina). All eligible participants receiving background treatment of aspirin plus clopidogrel or ticagrelor will be randomly assigned to either oral rivaroxaban 2.5 mg… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Myocardial Infarction, Myocardial Ischemia
- What is being tested?
- Rivaroxaban 2.5 mg, Rivaroxaban 5 mg and Enoxaparin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,055 participants
- Where
- 24 sitesChina
- Study dates
- 15 Jan 2018to 30 Nov 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged ≥ 18 years
- Diagnosed with ACS (STEMI, NSTEMI, unstable angina)
- With an indication for short-term combination use of DAPT and enoxaparin.
Who cannot join
- Already received thrombolytic therapy or revascularization or needing revascularization therapy in 12 hours.
- With platelet glycoprotein IIb/IIIa receptor antagonist therapy.
- With increased bleeding risk, such as but not limited to, active internal bleeding, clinically significant bleeding, bleeding at a non-compressible site, or bleeding diathesis within 30 days of randomization; platelet count less than 90,000/μL at screening; intracranial hemorrhage; major surgery, biopsy of a parenchymal organ, or serious trauma within 30 days before randomization; clinically significant gastrointestinal bleeding within 12 months before randomization; an international normalized ratio known to be>1.5 at the time of screening; abciximab bolus or infusion within the preceding 8 hours, or an eptifibatide or tirofiban bolus or infusion within the past 2 hours preceding randomization; or any other condition known to increase the risk of bleeding.
- Severe concomitant condition or disease, such as cardiogenic shock at the time of randomization, ventricular arrhythmia refractory to treatment at the time of randomization, calculated creatinine clearance b 30 mL/min at screening, known significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis), or liver function test abnormalities (confirmed with repeat testing) which would require study drug discontinuation, i.e., aminoleucine transferase (ALT) >5 × the upper limit of the normal range (ULN) or ALT >3 × ULN plus total bilirubin >2 × ULN, prior ischemic stroke or transient ischemia attack, anemia (i.e., hemoglobin < 10 g/ dL＝ at screening, known clinical history of human immunodeficiency virus infection at screening, substance abuse (drug or alcohol) problem within the previous 6 months or any severe condition such as cancer that would limit life expectancy to less than 6 months.
- With an indication for long-term oral anticoagulation therapy such as atrial fibrillation, venous thromboembolism, or prior placement of a mechanical heart valve.
- With other contraindications for use of rivaroxaban and enoxaparin.
- Enrolled in another clinical study.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
China24 sites
The First People's Hospital of Changde City
Changde, Hunan, 415003
Changsha Central Hospital
Changsha, Hunan, 410004
Hunan Provincial People's Hospital, The First Affiliated Hospital of Hunan Normal University
Changsha, Hunan, 410005
The Forth Hospital of Changsha
Changsha, Hunan, 410006
The First Affiliated Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, 410007
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
The First Hospital of Changsha
Changsha, Hunan, 410013
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
The Third Hospital of Changsha
Changsha, Hunan, 410015
The Second People's Hospital of Hunan Province
Changsha, Hunan, 430100
The First People's Hospital of Chenzhou
Chenzhou, Hunan, 423000
The First Affiliated Hospital of University of South China
Hengyang, Hunan, 421001
The Second Affiliated Hospital of University of South China
Hengyang, Hunan, 421001
The First Affiliated Hospital of Hunan University of Medicine
Huaihua, Hunan, 418000
The First People's Hospital of Huaihua
Huaihua, Hunan, 418000
The First Affiliated Hospital of Jishou University
Jishou, Hunan, 416000
The First People's Hospital of Loudi
Loudi, Hunan, 417000
The Central Hospital of Shaoyang
Shaoyang, Hunan, 422000
Xiangtan Central Hospital
Xiangtan, Hunan, 411413
Xiangxiang People's Hospital
Xianxiang, Hunan, 411400
Yiyang Central Hospital
Yiyang, Hunan, 413000
Yongzhou First People's Hospital
Yongzhou, Hunan, 425000
The First People's Hospital of Yueyang
Yueyang, Hunan, 414000
Zhuzhou Central Hospital
Zhuzhou, Hunan, 412007
About this study
Official title: Safety and Efficacy of Low Molecular Weight Heparin Versus Rivaroxaban in Chinese Patients Hospitalized With Acute Coronary Syndrome(H-REPLACE): a Prospective, Randomized, Open-label, Active-controlled, Multicenter Trial
H-REPLACE trial is a prospective, randomized, open-label, active-controlled, multicenter study in participants with ACS (STEMI or NSTEMI, unstable angina). All eligible participants receiving background treatment of aspirin plus clopidogrel or ticagrelor will be randomly assigned to either oral rivaroxaban 2.5 mg twice daily or rivaroxaban 5 mg twice daily or subcutaneous (SC) enoxaparin 1mg/kg twice daily until hospital discharge or 12 hours before revascularization therapy for a maximum of 8 days.
Read the detailed description
Acute coronary syndrome (ACS) is a serious and life threatening condition. Anticoagulation during the acute phase of ACS is effective in reducing ischaemic events. The combination regimen of anticoagulation with dual antiplatelet therapy (DAPT) strategy is more effective than either treatment alone. The most widely used parenteral anticoagulation agent in ACS patients is enoxaparin (1 mg/kg administered subcutaneously twice daily).
Rivaroxaban is a novel oral anticoagulant with potent anti-Xa activity, which might be an attractive alternative drug to enoxaparin. In fact, rivaroxaban was consistently shown to be non-inferior to enoxaparin therapy aimed to reduce the event of recurrent venous thromboembolism. Moreover, the bleeding risk of low dose of rivaroxaban is low and acceptable (1.0-2.5%) during the acute phase of ACS as shown by ATLAS ACS-TIMI 46 Trial, and the bleeding risk of enoxaparin during the acute phase of ACS was 4.3% as shown in a meta-analysis.
We thus hypothesized that the safety and efficacy of rivaroxaban during the acute phase of ACS is non-inferior to enoxaparin and designed this prospective, randomized, open-label, active-controlled, multicenter study in participants with ACS (STEMI or NSTEMI or unstable angina). All eligible participants receiving background treatment of aspirin plus clopidogrel or ticagrelor will be randomly assigned to either receive oral rivaroxaban 2.5 mg twice daily or oral rivaroxaban 5 mg twice daily or enoxaparin 1mg/kg twice daily SC until hospital discharge or 12 hours before revascularization therapy for a maximum of 8 days.
- Being tested
- Rivaroxaban 2.5 mg, Rivaroxaban 5 mg, Enoxaparin
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction, Myocardial Ischemia, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban 2.5 mgDrug
Also called Xarelto
One 2.5 mg rivaroxaban tablet twice daily until hospital discharge or 12 hours before revascularization therapy for a maximum of 8 days.
Rivaroxaban 5 mgDrug
Also called Xarelto
One 5 mg rivaroxaban tablet twice daily until hospital discharge or 12 hours before revascularization therapy for a maximum of 8 days.
EnoxaparinDrug
Also called LWMH
Enoxaparin 1mg/kg twice daily SC until hospital discharge or 12 hours before revascularization therapy for a maximum of 8 days.
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban 2.5 mg | Experimental | One 2.5 mg rivaroxaban tablet twice daily Receives: Drug: Rivaroxaban 2.5 mg |
| Rivaroxaban 5 mg | Experimental | One 5 mg rivaroxaban tablet twice daily Receives: Drug: Rivaroxaban 5 mg |
| enoxaparin | Active comparator | Enoxaparin 1mg/kg twice daily SC twice daily Receives: Drug: Enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Outcome: The percentage of patients with minor, clinically relevant non-major (CRNM) and major bleeding [International Society on Thrombosis and Haemostasis (ISTH) definition of bleeding]
The percentage of patients with the first occurrence of bleeding event according to ISTH definition. The statistical analysis was based on the occurrence of the bleeding event from randomization to Month 6.
Measured: From the time of randomization (Day 1) up to completion of the follow up phase (Month 6)
Primary Efficacy Outcome: The percentage of patients with the composite endpoint of cardiac death, myocardial infarction, re-revascularization or stroke.
The percentage of patients with the first occurrence of the composite of death, myocardial infarction, re-revascularization or stroke. The statistical analysis was based on the time from randomization to the first occurrence of the event up to Month 6.
Measured: From the time of randomization (Day 1) up to completion of the follow up phase (Month 6).
Secondary outcomes (2)
The percentage of patients with the cardiac-related rehospitalization.
The percentage of patients with the cardiac-related rehospitalization. The statistical analysis was based on the time from randomization to the first occurrence of the event up to Month 6.
Measured: From the time of randomization (Day 1) up to completion of the follow up phase (Month 6).
The percentage of patients with the all-cause death.
The percentage of patients with the all-cause death. The statistical analysis was based on the time from randomization to the first occurrence of the event up to Month 6.
Measured: From the time of randomization (Day 1) up to completion of the follow up phase (Month 6).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start15 Jan 2018
- Primary completion11 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,055 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shenghua Zhou, Second Xiangya Hospital of Central South University
- Investigators
- Shenghua Zhou, Ph.D., Principal investigator, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03363035
- Sponsor's protocol ID
- H-REPLACE-201711
- Acronym
- H-REPLACE
- Status last verified
- Feb 2022
- First submitted
- 29 Nov 2017
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang Q, Ding H, Dai Z, Yang R, Zhou S, Tai S. U-shaped association between plasma cyclic guanosine monophosphate-adenosine monophosphate (cGAMP) levels and myocardial infarction. BMC Cardiovasc Disord. 2025 Feb 19;25(1):116. doi: 10.1186/s12872-025-04543-9.
PubMed 39972291Zhou S, Xiao Y, Zhou C, Zheng Z, Jiang W, Shen Q, Zhu C, Pan H, Liu C, Zeng G, Ge L, Zhang Y, Ouyang Z, Fu G, Pan G, Chen F, Huang L, Liu Q; H-REPLACE Investigators. Effect of Rivaroxaban vs Enoxaparin on Major Cardiac Adverse Events and Bleeding Risk in the Acute Phase of Acute Coronary Syndrome: The H-REPLACE Randomized Equivalence and Noninferiority Trial. JAMA Netw Open. 2023 Feb 1;6(2):e2255709. doi: 10.1001/jamanetworkopen.2022.55709.
PubMed 36763358Xiao Y, Tang L, Liu Q, Hu X, Fang Z, Zhou S. Rationale and Design of the H-REPLACE Study: Safety and Efficacy of LMWH Versus Rivaroxaban in ChinEse Patients HospitaLized with Acute Coronary SyndromE. Cardiovasc Drugs Ther. 2022 Feb;36(1):69-73. doi: 10.1007/s10557-020-07076-9. Epub 2020 Sep 23.
PubMed 32965585
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Low Molecular Weight Heparin Versus Rivaroxaban in Chinese Patients Hospitalized With Acute Coronary Syndrome(H-REPLACE): a Prospective, Randomized, Open-label, Active-controlled, Multicenter Trial
- ClinicalTrials.gov ID
- NCT03363035
- Acronym / sponsor ID
- H-REPLACE / H-REPLACE-201711
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,055 participants (actual)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 11 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 5 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
H-REPLACE trial is a prospective, randomized, open-label, active-controlled, multicenter study in participants with ACS (STEMI or NSTEMI, unstable angina). All eligible participants receiving background treatment of aspirin plus clopidogrel or ticagrelor will be randomly assigned to either oral rivaroxaban 2.5 mg twice daily or rivaroxaban 5 mg twice daily or subcutaneous (SC) enoxaparin 1mg/kg twice daily until hospital discharge or 12 hours before revascularization therapy for a maximum of 8 days.
Detailed description
Acute coronary syndrome (ACS) is a serious and life threatening condition. Anticoagulation during the acute phase of ACS is effective in reducing ischaemic events. The combination regimen of anticoagulation with dual antiplatelet therapy (DAPT) strategy is more effective than either treatment alone. The most widely used parenteral anticoagulation agent in ACS patients is enoxaparin (1 mg/kg administered subcutaneously twice daily).
Rivaroxaban is a novel oral anticoagulant with potent anti-Xa activity, which might be an attractive alternative drug to enoxaparin. In fact, rivaroxaban was consistently shown to be non-inferior to enoxaparin therapy aimed to reduce the event of recurrent venous thromboembolism. Moreover, the bleeding risk of low dose of rivaroxaban is low and acceptable (1.0-2.5%) during the acute phase of ACS as shown by ATLAS ACS-TIMI 46 Trial, and the bleeding risk of enoxaparin during the acute phase of ACS was 4.3% as shown in a meta-analysis.
We thus hypothesized that the safety and efficacy of rivaroxaban during the acute phase of ACS is non-inferior to enoxaparin and designed this prospective, randomized, open-label, active-controlled, multicenter study in participants with ACS (STEMI or NSTEMI or unstable angina). All eligible participants receiving background treatment of aspirin plus clopidogrel or ticagrelor will be randomly assigned to either receive oral rivaroxaban 2.5 mg twice daily or oral rivaroxaban 5 mg twice daily or enoxaparin 1mg/kg twice daily SC until hospital discharge or 12 hours before revascularization therapy for a maximum of 8 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban 2.5 mg | Experimental | Drug: Rivaroxaban 2.5 mgOne 2.5 mg rivaroxaban tablet twice daily |
| Rivaroxaban 5 mg | Experimental | Drug: Rivaroxaban 5 mgOne 5 mg rivaroxaban tablet twice daily |
| enoxaparin | Active comparator | Drug: EnoxaparinEnoxaparin 1mg/kg twice daily SC twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female aged ≥ 18 years
- Diagnosed with ACS (STEMI, NSTEMI, unstable angina)
- With an indication for short-term combination use of DAPT and enoxaparin.
Key exclusion criteria (7 listed)
- Already received thrombolytic therapy or revascularization or needing revascularization therapy in 12 hours.
- With platelet glycoprotein IIb/IIIa receptor antagonist therapy.
- With increased bleeding risk, such as but not limited to, active internal bleeding, clinically significant bleeding, bleeding at a non-compressible site, or bleeding diathesis within 30 days of randomization; platelet count less than 90,000/μL at screening; intracranial hemorrhage; major surgery, biopsy of a parenchymal organ, or serious trauma within 30 days before randomization; clinically significant gastrointestinal bleeding within 12 months before randomization; an international normalized ratio known to be>1.5 at the time of screening; abciximab bolus or infusion within the preceding 8 hours, or an eptifibatide or tirofiban bolus or infusion within the past 2 hours preceding randomization; or any other condition known to increase the risk of bleeding.
- Severe concomitant condition or disease, such as cardiogenic shock at the time of randomization, ventricular arrhythmia refractory to treatment at the time of randomization, calculated creatinine clearance b 30 mL/min at screening, known significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis), or liver function test abnormalities (confirmed with repeat testing) which would require study drug discontinuation, i.e., aminoleucine transferase (ALT) >5 × the upper limit of the normal range (ULN) or ALT >3 × ULN plus total bilirubin >2 × ULN, prior ischemic stroke or transient ischemia attack, anemia (i.e., hemoglobin < 10 g/ dL＝ at screening, known clinical history of human immunodeficiency virus infection at screening, substance abuse (drug or alcohol) problem within the previous 6 months or any severe condition such as cancer that would limit life expectancy to less than 6 months.
- With an indication for long-term oral anticoagulation therapy such as atrial fibrillation, venous thromboembolism, or prior placement of a mechanical heart valve.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivaroxaban 2.5 mgAlso: XareltoOne 2.5 mg rivaroxaban tablet twice daily until hospital discharge or 12 hours before revascularization therapy for a maximum of 8 days. | Drug | Rivaroxaban 2.5 mg |
| Rivaroxaban 5 mgAlso: XareltoOne 5 mg rivaroxaban tablet twice daily until hospital discharge or 12 hours before revascularization therapy for a maximum of 8 days. | Drug | Rivaroxaban 5 mg |
| EnoxaparinAlso: LWMHEnoxaparin 1mg/kg twice daily SC until hospital discharge or 12 hours before revascularization therapy for a maximum of 8 days. | Drug | enoxaparin |
Primary outcome
Primary Safety Outcome: The percentage of patients with minor, clinically relevant non-major (CRNM) and major bleeding [International Society on Thrombosis and Haemostasis (ISTH) definition of bleeding]
Time frame: From the time of randomization (Day 1) up to completion of the follow up phase (Month 6)
The percentage of patients with the first occurrence of bleeding event according to ISTH definition. The statistical analysis was based on the occurrence of the bleeding event from randomization to Month 6.
Primary Efficacy Outcome: The percentage of patients with the composite endpoint of cardiac death, myocardial infarction, re-revascularization or stroke.
Time frame: From the time of randomization (Day 1) up to completion of the follow up phase (Month 6).
The percentage of patients with the first occurrence of the composite of death, myocardial infarction, re-revascularization or stroke. The statistical analysis was based on the time from randomization to the first occurrence of the event up to Month 6.
2 secondary outcomes
The percentage of patients with the cardiac-related rehospitalization.
Time frame: From the time of randomization (Day 1) up to completion of the follow up phase (Month 6).
The percentage of patients with the all-cause death.
Time frame: From the time of randomization (Day 1) up to completion of the follow up phase (Month 6).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Derived from this study: PubMed 39972291Zhang Q, Ding H, Dai Z, Yang R, Zhou S, Tai S. U-shaped association between plasma cyclic guanosine monophosphate-adenosine monophosphate (cGAMP) levels and myocardial infarction. BMC Cardiovasc Disord. 2025 Feb 19;25(1):116. doi: 10.1186/s12872-025-04543-9.
- Derived from this study: PubMed 36763358Zhou S, Xiao Y, Zhou C, Zheng Z, Jiang W, Shen Q, Zhu C, Pan H, Liu C, Zeng G, Ge L, Zhang Y, Ouyang Z, Fu G, Pan G, Chen F, Huang L, Liu Q; H-REPLACE Investigators. Effect of Rivaroxaban vs Enoxaparin on Major Cardiac Adverse Events and Bleeding Risk in the Acute Phase of Acute Coronary Syndrome: The H-REPLACE Randomized Equivalence and Noninferiority Trial. JAMA Netw Open. 2023 Feb 1;6(2):e2255709. doi: 10.1001/jamanetworkopen.2022.55709.
- Derived from this study: PubMed 32965585Xiao Y, Tang L, Liu Q, Hu X, Fang Z, Zhou S. Rationale and Design of the H-REPLACE Study: Safety and Efficacy of LMWH Versus Rivaroxaban in ChinEse Patients HospitaLized with Acute Coronary SyndromE. Cardiovasc Drugs Ther. 2022 Feb;36(1):69-73. doi: 10.1007/s10557-020-07076-9. Epub 2020 Sep 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shenghua Zhou, Ph.D. principal investigator
Second Xiangya Hospital of Central South University
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rivaroxaban 2.5 mg, Rivaroxaban 5 mg and Enoxaparin in people with Acute Coronary Syndrome and Myocardial Infarction, run by Second Xiangya Hospital of Central South University at 24 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Outcome: The percentage of patients with minor, clinically relevant non-major (CRNM) and major bleeding [International Society on Thrombosis and Haemostasis (ISTH) definition of bleeding] (time frame: From the time of randomization (Day 1) up to completion of the follow up phase (Month 6)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03363035, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2022; AzTrials last refreshed its copy on 8 Nov 2026.