Transcatheter Aortic Valve ReplacementPhase 4NCT05375474
Antithrombotic Strategy Based on Clinical Events and 4D-CT for Patients After TAVR
A Phase 4 study testing Oral anticoagulation therapy and Single antiplatelet therapy in people with Transcatheter Aortic Valve Replacement and Antithrombotic Therapy, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
This is a multicenter, open-label, randomized controlled study meant to test the superior efficacy of oral anticoagulation (OAC) therapy versus single antiplatelet therapy (SAPT) in patients after TAVR. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Transcatheter Aortic Valve Replacement, Antithrombotic Therapy, Bioprosthetic Valve Thrombosis
- What is being tested?
- Oral anticoagulation therapy and Single antiplatelet therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 1 siteChina
- Study dates
- 27 Jul 2023to 31 Dec 2025
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-85 years old with severe aortic stenosis;
- Successful TAVR via femoral artery approach (VARC 3 device success criteria);
- Implantation of self-expanding bioprosthetic valve;
- Be willing to give informed consent.
Who cannot join
- Patients with anticoagulant indications, such as atrial fibrillation, intracardiac thrombosis, deep vein thrombosis, pulmonary embolism, history of mechanical valve implantation;
- Patients needed double antiplatelet therapy, such as acute myocardial infarction within one year, coronary stent implantation within 6 months, peripheral artery stent implantation within 3 months;
- Patients who received concomitant TAVR and percutaneous coronary intervention;
- Patients with peptic ulcers or active bleeding or history of cerebral hemorrhage
- Patients with ischemic stroke or TIA within 6 months;
- Patients with left ventricular ejection fraction < 30% or pulmonary hypertension (>70mmHg) before discharge;
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- Patients intolerant or allergic to aspirin or Vitamin-K antagonists (warfarin);
- Patients with evaluated glomerular filtration rate <15ml/min/m2 (Cockcroft formula) or on dialysis;
- Patients with poor compliance, unable to complete the study and follow-up as required;
- Patients' life expectancy less than 1 year;
- Patients who already participated in other clinical trials (within the last 30 days).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai hospital
Beijing, Beijing Municipality, 100037
Yongjian Wu, MD, PhD, +86 13701387189, yongjianwu_nccd@163.com
About this study
This is a multicenter, open-label, randomized controlled study meant to test the superior efficacy of oral anticoagulation (OAC) therapy versus single antiplatelet therapy (SAPT) in patients after TAVR. Patients who accept successful TAVR will be randomized to receive either the OAC group (Vitamin-K antagonists) or the SAPT group (aspirin) for 6 months on a 1:1 ratio. After that, patients from both groups will be treated with single antiplatelet therapy (aspirin). All patients will be followed for 1 year to test the difference between net clinical benefits and bioprosthetic valve thrombosis diagnosed by 4D-CT.
- Conditions
- Transcatheter Aortic Valve Replacement, Antithrombotic Therapy, Bioprosthetic Valve Thrombosis
- Being tested
- Oral anticoagulation therapy, Single antiplatelet therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral anticoagulation therapyDrug
Vitamin-K antagonists (warfarin)
Single antiplatelet therapyDrug
Aspirin
| Study group | Role | What they receive |
|---|---|---|
| Oral anticoagulation therapy group | Experimental | Vitamin-K antagonists (warfarin), therapeutic INR: 1.8-2.5 Receives: Drug: Oral anticoagulation therapy |
| Single antiplatelet therapy group | Active comparator | Aspirin, 75-100mg Receives: Drug: Single antiplatelet therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite of all-cause mortality, myocardial infarction, stroke, TIA, peripheral artery thrombosis, intracardiac thrombosis, major bleeding (BARC 3a), and disabling/life-threatening bleeding (BARC 3b,3c,5)
A composite of all-cause mortality, myocardial infarction, stroke, TIA, peripheral artery thrombosis, intracardiac thrombosis, major bleeding (BARC 3a), and disabling/life-threatening bleeding (BARC 3b,3c,5)
Measured: 1 year
Rates of bioprosthetic valve thrombosis detected by 4D-CT
Measured: 1 year
Secondary outcomes (13)
A composite of all-cause mortality, myocardial infarction, stroke, TIA, peripheral artery thrombosis, intracardiac thrombosis
A composite of all-cause mortality, myocardial infarction, stroke, TIA, peripheral artery thrombosis, intracardiac thrombosis
Measured: 1 year
Major bleeding (BARC 3a), and disabling/life-threatening bleeding (BARC 3b,3c,5)
Major bleeding (BARC 3a), and disabling/life-threatening bleeding (BARC 3b,3c,5)
Measured: 1 year
Cardiac death
Cardiac death
Measured: 1 year
Minor bleeding (BRAC 2)
Minor bleeding (BRAC 2)
Measured: 1 year
Bleeding (BRAC 1, 2, 3a-c, 5)
Bleeding (BRAC 1, 2, 3a-c, 5)
Measured: 1 year
All-cause mortality
All-cause mortality
Measured: 1 year
Myocardial infarction
Myocardial infarction
Measured: 1 year
Stroke
Stroke
Measured: 1 year
TIA
TIA
Measured: 1 year
Peripheral artery thrombosis
Peripheral artery thrombosis
Measured: 1 year
Intracardiac thrombosis
Intracardiac thrombosis
Measured: 1 year
Major bleeding (BARC 3a)
Major bleeding (BARC 3a)
Measured: 1 year
Disabling/life-threatening bleeding (BARC 3b,3c,5)
Disabling/life-threatening bleeding (BARC 3b,3c,5)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start27 Jul 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transcatheter Aortic Valve ReplacementStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe 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
- 650 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yongjian Wu, MD, PhD, China National Center for Cardiovascular Diseases
- Investigators
- Yongjian Wu, MD,PhD, Study chair, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical SciencesYunqing Ye, Master, Study director, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05375474
- Sponsor's protocol ID
- CSC-20220504
- Status last verified
- Oct 2023
- First submitted
- 11 May 2022
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hu X, Xu H, Wang C, Wang Y, Wang Y, Zhou D, Zhu Q, Xu K, Yang J, Zhang H, Jiang N, Zhang J, Fang Z, Fu G, Guo Y, Li Y, Wang M, Feng D, Niu G, Zhang E, Chen Y, Ye Y, Wu Y. Early 6 months usage of single anTiplAtelet OR anTicoAgulant followed by single antiplatelet after transcatheter aortic valve replacement: protocol for a multicentre, open-label, randomised controlled clinical trial. BMJ Open. 2023 Nov 21;13(11):e076781. doi: 10.1136/bmjopen-2023-076781.
PubMed 37989381
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antithrombotic Strategy Based on Clinical Events and 4D-CT for Patients After TAVR
- ClinicalTrials.gov ID
- NCT05375474
- Acronym / sponsor ID
- CSC-20220504
- Conditions
- Transcatheter Aortic Valve Replacement, Antithrombotic Therapy, Bioprosthetic Valve Thrombosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 May 2022 (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.
This is a multicenter, open-label, randomized controlled study meant to test the superior efficacy of oral anticoagulation (OAC) therapy versus single antiplatelet therapy (SAPT) in patients after TAVR. Patients who accept successful TAVR will be randomized to receive either the OAC group (Vitamin-K antagonists) or the SAPT group (aspirin) for 6 months on a 1:1 ratio. After that, patients from both groups will be treated with single antiplatelet therapy (aspirin). All patients will be followed for 1 year to test the difference between net clinical benefits and bioprosthetic valve thrombosis diagnosed by 4D-CT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral anticoagulation therapy group | Experimental | Drug: Oral anticoagulation therapyVitamin-K antagonists (warfarin), therapeutic INR: 1.8-2.5 |
| Single antiplatelet therapy group | Active comparator | Drug: Single antiplatelet therapyAspirin, 75-100mg |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18-85 years old with severe aortic stenosis;
- Successful TAVR via femoral artery approach (VARC 3 device success criteria);
- Implantation of self-expanding bioprosthetic valve;
- Be willing to give informed consent.
Key exclusion criteria (11 listed)
- Patients with anticoagulant indications, such as atrial fibrillation, intracardiac thrombosis, deep vein thrombosis, pulmonary embolism, history of mechanical valve implantation;
- Patients needed double antiplatelet therapy, such as acute myocardial infarction within one year, coronary stent implantation within 6 months, peripheral artery stent implantation within 3 months;
- Patients who received concomitant TAVR and percutaneous coronary intervention;
- Patients with peptic ulcers or active bleeding or history of cerebral hemorrhage
- Patients with ischemic stroke or TIA within 6 months;
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 |
|---|---|---|
| Oral anticoagulation therapyVitamin-K antagonists (warfarin) | Drug | Oral anticoagulation therapy group |
| Single antiplatelet therapyAspirin | Drug | Single antiplatelet therapy group |
Primary outcome
A composite of all-cause mortality, myocardial infarction, stroke, TIA, peripheral artery thrombosis, intracardiac thrombosis, major bleeding (BARC 3a), and disabling/life-threatening bleeding (BARC 3b,3c,5)
Time frame: 1 year
A composite of all-cause mortality, myocardial infarction, stroke, TIA, peripheral artery thrombosis, intracardiac thrombosis, major bleeding (BARC 3a), and disabling/life-threatening bleeding (BARC 3b,3c,5)
Rates of bioprosthetic valve thrombosis detected by 4D-CT
Time frame: 1 year
13 secondary outcomes
A composite of all-cause mortality, myocardial infarction, stroke, TIA, peripheral artery thrombosis, intracardiac thrombosis
Time frame: 1 year
Major bleeding (BARC 3a), and disabling/life-threatening bleeding (BARC 3b,3c,5)
Time frame: 1 year
Cardiac death
Time frame: 1 year
Minor bleeding (BRAC 2)
Time frame: 1 year
Bleeding (BRAC 1, 2, 3a-c, 5)
Time frame: 1 year
All-cause mortality
Time frame: 1 year
Myocardial infarction
Time frame: 1 year
Stroke
Time frame: 1 year
TIA
Time frame: 1 year
Peripheral artery thrombosis
Time frame: 1 year
Intracardiac thrombosis
Time frame: 1 year
Major bleeding (BARC 3a)
Time frame: 1 year
Disabling/life-threatening bleeding (BARC 3b,3c,5)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 37989381Hu X, Xu H, Wang C, Wang Y, Wang Y, Zhou D, Zhu Q, Xu K, Yang J, Zhang H, Jiang N, Zhang J, Fang Z, Fu G, Guo Y, Li Y, Wang M, Feng D, Niu G, Zhang E, Chen Y, Ye Y, Wu Y. Early 6 months usage of single anTiplAtelet OR anTicoAgulant followed by single antiplatelet after transcatheter aortic valve replacement: protocol for a multicentre, open-label, randomised controlled clinical trial. BMJ Open. 2023 Nov 21;13(11):e076781. doi: 10.1136/bmjopen-2023-076781.
- Individual participant dataSharing planned: No
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Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
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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.
Yongjian Wu, MD,PhD study chair
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
Yunqing Ye, Master study director
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral anticoagulation therapy and Single antiplatelet therapy in people with Transcatheter Aortic Valve Replacement and Antithrombotic Therapy, run by China National Center for Cardiovascular Diseases at 1 site 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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yongjian Wu, MD,PhD (+86 13701387189, yongjianwu_nccd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite of all-cause mortality, myocardial infarction, stroke, TIA, peripheral artery thrombosis, intracardiac thrombosis, major bleeding (BARC 3a), and disabling/life-threatening bleeding (BARC 3b,3c,5) (time frame: 1 year). 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 NCT05375474, which also lists 1 linked publication.
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 23 Oct 2023.