Acute Coronary SyndromeNCT05750758
Rivaroxaban Combined With DAPT Versus DAPT Alone After Drug-coated Balloon Angioplasty
A study testing rivaroxaban in people with Acute Coronary Syndrome, run by Henan Institute of Cardiovascular Epidemiology at 1 site in China.
Trial summary
The target population of this interventional study was ACS patients with drug-coated balloons. The main discussion : 1.1 months of rivaroxaban combined with dual antiplatelet therapy compared with dual antiplatelet therapy alone, late lumen loss at 6 months. 2. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- rivaroxaban
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2023to 1 Dec 2023
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ACS patients who meet the indications of percutaneous coronary intervention
- The reference diameter of the target vessel was ≥2.75mm
- Target lesions were treated with a drug-coated balloon catheter (DCB) for PCI
- According to IVUS assessment, the target lesions were dissected and accumulated medium without affecting distal blood flow
Who cannot join
- <18 or >60 years old
- Bridging vessels or stent restenosis
- Unable to sign written informed consent
- Female patients during pregnancy or lactation (for women who have not stopped menstruation, pregnancy test should be performed within 7 days prior to enrollment in this study)
- Antiplatelet agents and anticoagulants are not available; Have heparin, contrast agent and other allergies
- The subjects were participating in other uncompleted clinical trials
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- Scheduled elective surgery
- Life expectancy is less than 1 year
- Patients with high blood risk
- Has long-term oral anticoagulant therapy adaptation
- Cardiogenic shock
- Patients with severe intraoperative dissection or hematoma requiring stent rescue
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Rivaroxaban Combined With Dual Antiplatelet Therapy Versus Dual Antiplatelet Therapy Alone 1 Month After Drug-coated Balloon Angioplasty in Patients With Acute Coronary Syndrome Without High Bleeding Risk
The target population of this interventional study was ACS patients with drug-coated balloons. The main discussion : 1.1 months of rivaroxaban combined with dual antiplatelet therapy compared with dual antiplatelet therapy alone, late lumen loss at 6 months. 2. To determine the safety of the regimen with bleeding events as the end point. Subjects were randomly assigned to two groups, one receiving routine DAPT for six months and one receiving DAPT plus one month of rivaroxaban 2.5 mg bid
Read the detailed description
Drug-coated balloon ( DCB ) is to apply anti-intimal hyperplasia drugs to the surface of the balloon. When the balloon reaches the diseased blood vessel and is stretched and expanded, it contacts the intima of the blood vessel wall. By tearing the intima of the blood vessel and pressing, the transfer drug is quickly released to the intima of the blood vessel, thereby preventing restenosis after vascular intervention. Pretreatment is a key step in the use of drug balloons in situ macroangiopathy. At present, it is required that the residual stenosis of the lesion during pretreatment is ≤ 30 %, and there is no distal blood flow restrictive dissection and hematoma. The relationship between dissection hematoma and residual stenosis is difficult to deal with. Some small dissections are beneficial to the absorption of DCB anti-proliferative drugs by the vascular wall. The larger dissection may cause the thrombus to persist in the vascular wall, resulting in late lumen loss after organization. Rivaroxaban is a new oral anticoagulant, which is gradually used in the treatment of coronary heart disease. At present, there is no clinical study on the prognosis of vascular dissection in DCB. Based on the above research background, we designed the following trial, aimed to study in ACS population, vascular lumen access + hemorrhagic events as the end point, try to clear 1 month rivaroxaban combined with dual antiplatelet therapy compared with single dual antiplatelet therapy effect.
- Conditions
- Acute Coronary Syndrome
- Being tested
- rivaroxaban
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rivaroxabanDrug
rivaroxaban 2.5mg bid for 1m
| Study group | Role | What they receive |
|---|---|---|
| DAPT+rivaroxaban | Experimental | Rivaroxaban 2.5 mg bid + aspirin 100 mg qd + ticagrelor 90 mg bid was used for 1 month after operation, and then aspirin 100 mg + ticagrelor 90 mg bid was used for 5 months. Receives: Drug: rivaroxaban |
| DAPT | No intervention | aspirin 100 mg qd + ticagrelor 90 mg bid for 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
late lumen loss ( LLL)
Evaluation of postoperative target vessel LLL at follow-up using QCA
Measured: 6 months
Secondary outcomes (6)
Vascular dissection healing
Re-use CAG to evaluate the vascular reexamination of the original dissection
Measured: 6 months
Minimum lumen area
using CAG
Measured: 6 months
Cardiovascular death
All deaths are counted as cardiovascular deaths unless there is a clear determination of other causes
Measured: 6 months
Target vessel myocardial infarction
CAG confirms
Measured: 6 months
Clinical-driven revascularization of target lesions
Clinical-driven revascularization of target lesions
Measured: 6 months
Bleeding events defined by BARC
Bleeding events defined by BARC
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start20 Feb 2023
- Primary completion10 Aug 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan Institute of Cardiovascular Epidemiology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muwei Li, MD, Study chair, Fuwai central China cardiovascular hospotial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750758
- Sponsor's protocol ID
- HenanICE202203
- Status last verified
- Feb 2024
- First submitted
- 20 Feb 2023
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Rivaroxaban Combined With Dual Antiplatelet Therapy Versus Dual Antiplatelet Therapy Alone 1 Month After Drug-coated Balloon Angioplasty in Patients With Acute Coronary Syndrome Without High Bleeding Risk
- ClinicalTrials.gov ID
- NCT05750758
- Acronym / sponsor ID
- HenanICE202203
- Conditions
- Acute Coronary Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Henan Institute of Cardiovascular EpidemiologyUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 2 Mar 2023 (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.
The target population of this interventional study was ACS patients with drug-coated balloons. The main discussion : 1.1 months of rivaroxaban combined with dual antiplatelet therapy compared with dual antiplatelet therapy alone, late lumen loss at 6 months. 2. To determine the safety of the regimen with bleeding events as the end point. Subjects were randomly assigned to two groups, one receiving routine DAPT for six months and one receiving DAPT plus one month of rivaroxaban 2.5 mg bid
Detailed description
Drug-coated balloon ( DCB ) is to apply anti-intimal hyperplasia drugs to the surface of the balloon. When the balloon reaches the diseased blood vessel and is stretched and expanded, it contacts the intima of the blood vessel wall. By tearing the intima of the blood vessel and pressing, the transfer drug is quickly released to the intima of the blood vessel, thereby preventing restenosis after vascular intervention. Pretreatment is a key step in the use of drug balloons in situ macroangiopathy. At present, it is required that the residual stenosis of the lesion during pretreatment is ≤ 30 %, and there is no distal blood flow restrictive dissection and hematoma. The relationship between dissection hematoma and residual stenosis is difficult to deal with. Some small dissections are beneficial to the absorption of DCB anti-proliferative drugs by the vascular wall. The larger dissection may cause the thrombus to persist in the vascular wall, resulting in late lumen loss after organization. Rivaroxaban is a new oral anticoagulant, which is gradually used in the treatment of coronary heart disease. At present, there is no clinical study on the prognosis of vascular dissection in DCB. Based on the above research background, we designed the following trial, aimed to study in ACS population, vascular lumen access + hemorrhagic events as the end point, try to clear 1 month rivaroxaban combined with dual antiplatelet therapy compared with single dual antiplatelet therapy effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DAPT+rivaroxaban | Experimental | Drug: rivaroxabanRivaroxaban 2.5 mg bid + aspirin 100 mg qd + ticagrelor 90 mg bid was used for 1 month after operation, and then aspirin 100 mg + ticagrelor 90 mg bid was used for 5 months. |
| DAPT | No intervention | –aspirin 100 mg qd + ticagrelor 90 mg bid for 6 months. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ACS patients who meet the indications of percutaneous coronary intervention
- The reference diameter of the target vessel was ≥2.75mm
- Target lesions were treated with a drug-coated balloon catheter (DCB) for PCI
- According to IVUS assessment, the target lesions were dissected and accumulated medium without affecting distal blood flow
Key exclusion criteria (12 listed)
- <18 or >60 years old
- Bridging vessels or stent restenosis
- Unable to sign written informed consent
- Female patients during pregnancy or lactation (for women who have not stopped menstruation, pregnancy test should be performed within 7 days prior to enrollment in this study)
- Antiplatelet agents and anticoagulants are not available; Have heparin, contrast agent and other allergies
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 |
|---|---|---|
| rivaroxabanrivaroxaban 2.5mg bid for 1m | Drug | DAPT+rivaroxaban |
Primary outcome
late lumen loss ( LLL)
Time frame: 6 months
Evaluation of postoperative target vessel LLL at follow-up using QCA
6 secondary outcomes
Vascular dissection healing
Time frame: 6 months
Minimum lumen area
Time frame: 6 months
Cardiovascular death
Time frame: 6 months
Target vessel myocardial infarction
Time frame: 6 months
Clinical-driven revascularization of target lesions
Time frame: 6 months
Bleeding events defined by BARC
Time frame: 6 months
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 23 Feb 2024.
- 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.
Muwei Li, MD study chair
Fuwai central China cardiovascular hospotial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rivaroxaban in people with Acute Coronary Syndrome, run by Henan Institute of Cardiovascular Epidemiology 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 12 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 23 Feb 2024. 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.
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?
late lumen loss ( LLL) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2024.