Anticoagulant DrugsNCT05852197
Effect of Anticoagulant Drug Intervention on Postoperative MALE and MACE in Patients With PAD
An observational study of Anticoagulant Drugs and Antiplatelet Drug, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
Patients with PAD were grouped according to the combination of different anticoagulant and antiplate drugs. The type, dosage and duration of anticoagulant and antiplatelet drugs were recorded after operation. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Anticoagulant Drugs, Antiplatelet Drug, Peripheral Arterial Disease
- What is being tested?
- anticoagulant or antiplatelet drugs
- How many people
- 6,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 1 Jan 2026
- Phase
- Observational
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Intracavitary therapy for lower extremity arteriosclerosis obliterans
Who may be able to join
- Age ≥50 years old
- Patients with symptomatic PAD
- Moderate intermittent claudication, or severe limb ischemia
- Radiographically confirmed occlusion
- Received a successful revascularization
Who cannot join
- Acute limb ischemia occurred within 2 weeks before revascularization;
- Large tissue defect of any lower limb (defined as obvious ulceration/gangrene near phalangeal head);
- After revascularization, there are clinical conditions requiring systemic anticoagulation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Zhejiang University
Hangzhou, None Selected, 310003
Ziheng Wu, 13757150163, wuziheng@zju.edu.cn
About this study
Official title: Effect of Anticoagulant Drug Intervention on postoperativeMajor Adverse Limb Events and Major Adverse Cardiovascular Events in Patients With Peripheral Arterial Disease
Patients with PAD were grouped according to the combination of different anticoagulant and antiplate drugs. The type, dosage and duration of anticoagulant and antiplatelet drugs were recorded after operation. Major Adverse Cardiovascular Events and Major Adverse Limb Events were followed up at 1 month, 6 months and 12 months, respectively.
- Being tested
- anticoagulant or antiplatelet drugs
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anticoagulant or antiplatelet drugsDrug
combination of anticoagulant or antiplatelet drugs
| Study group | Role | What they receive |
|---|---|---|
| Use a combination of anticoagulant or antiplatelet drugs ， group 1 | Not described Receives: Drug: anticoagulant or antiplatelet drugs | |
| Use a combination of anticoagulant or antiplatelet drugs， group 2 | Not described Receives: Drug: anticoagulant or antiplatelet drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite adverse event incidence (MACE/MALE) : myocardial infarction, ischemic stroke, acute limb ischemia, major amputation due to vascular disease
The incidence of myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation owing to vascular disease after the treatment. Measured in the first, sixth, ninth, and twelfth month.
Measured: The 1st month after treatment
Composite adverse event incidence (MACE/MALE) : myocardial infarction, ischemic stroke, acute limb ischemia, major amputation due to vascular disease
The incidence of myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation owing to vascular disease after the treatment. Measured in the first, sixth, ninth, and twelfth month.
Measured: The 3rd month after treatment
Composite adverse event incidence (MACE/MALE) : myocardial infarction, ischemic stroke, acute limb ischemia, major amputation due to vascular disease
The incidence of myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation owing to vascular disease after the treatment. Measured in the first, sixth, ninth, and twelfth month.
Measured: The 6th month after treatment
Composite adverse event incidence (MACE/MALE) : myocardial infarction, ischemic stroke, acute limb ischemia, major amputation due to vascular disease
The incidence of myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation owing to vascular disease after the treatment. Measured in the first, sixth, ninth, and twelfth month.
Measured: The 9th month after treatment
Composite adverse event incidence (MACE/MALE) : myocardial infarction, ischemic stroke, acute limb ischemia, major amputation due to vascular disease
The incidence of myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation owing to vascular disease after the treatment. Measured in the first, sixth, ninth, and twelfth month.
Measured: The 12th month after treatment
Secondary outcomes (5)
MACE
The incidence of myocardial infarction, ischemic stroke owing to vascular disease after the treatment. Measured in the first, sixth, ninth, and twelfth month.
Measured: The 1st，3rd，6th，9th，12th month
MALE
The incidence of acute limb ischemia, major amputation due to vascular disease owing to vascular disease after the treatment. Measured in the first, sixth, ninth, and twelfth month.
Measured: The 1st，3rd，6th，9th，12th month
Compound protection from vasogenic adverse events
The incidence of muscle infarction, ischemic stroke, acute limb ischemia, major amputation due to vascular disease, massive bleeding after the treatment. Measured in the first, sixth, ninth, and twelfth month.
Measured: The 1st，3rd，6th，9th，12th month
all-cause mortality
Deaths occurring during follow-up, regardless of cause
Measured: The 1st，3rd，6th，9th，12th month
health economics evaluation
The cost of patient treatment
Measured: The 1st，3rd，6th，9th，12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start1 Jan 2023
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anticoagulant DrugsStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852197
- Sponsor's protocol ID
- IIT20230084B
- Status last verified
- Feb 2023
- First submitted
- 22 Apr 2023
- Last updated
- 10 May 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: With the consent of the committee, it can be based on patient data
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anticoagulant Drug Intervention on postoperativeMajor Adverse Limb Events and Major Adverse Cardiovascular Events in Patients With Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT05852197
- Acronym / sponsor ID
- IIT20230084B
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 10 May 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.
Patients with PAD were grouped according to the combination of different anticoagulant and antiplate drugs. The type, dosage and duration of anticoagulant and antiplatelet drugs were recorded after operation. Major Adverse Cardiovascular Events and Major Adverse Limb Events were followed up at 1 month, 6 months and 12 months, respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use a combination of anticoagulant or antiplatelet drugs ， group 1 | – | Drug: anticoagulant or antiplatelet drugs |
| Use a combination of anticoagulant or antiplatelet drugs， group 2 | – | Drug: anticoagulant or antiplatelet drugs |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intracavitary therapy for lower extremity arteriosclerosis obliterans
Key inclusion criteria (5 listed)
- Age ≥50 years old
- Patients with symptomatic PAD
- Moderate intermittent claudication, or severe limb ischemia
- Radiographically confirmed occlusion
- Received a successful revascularization
Key exclusion criteria (3 listed)
- Acute limb ischemia occurred within 2 weeks before revascularization;
- Large tissue defect of any lower limb (defined as obvious ulceration/gangrene near phalangeal head);
- After revascularization, there are clinical conditions requiring systemic anticoagulation
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 |
|---|---|---|
| anticoagulant or antiplatelet drugscombination of anticoagulant or antiplatelet drugs | Drug | Use a combination of anticoagulant or antiplatelet drugs ， group 1, Use a combination of anticoagulant or antiplatelet drugs， group 2 |
Primary outcome
Composite adverse event incidence (MACE/MALE) : myocardial infarction, ischemic stroke, acute limb ischemia, major amputation due to vascular disease
Time frame: The 1st month after treatment
The incidence of myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation owing to vascular disease after the treatment. Measured in the first, sixth, ninth, and twelfth month.
Composite adverse event incidence (MACE/MALE) : myocardial infarction, ischemic stroke, acute limb ischemia, major amputation due to vascular disease
Time frame: The 3rd month after treatment
The incidence of myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation owing to vascular disease after the treatment. Measured in the first, sixth, ninth, and twelfth month.
Composite adverse event incidence (MACE/MALE) : myocardial infarction, ischemic stroke, acute limb ischemia, major amputation due to vascular disease
Time frame: The 6th month after treatment
The incidence of myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation owing to vascular disease after the treatment. Measured in the first, sixth, ninth, and twelfth month.
Composite adverse event incidence (MACE/MALE) : myocardial infarction, ischemic stroke, acute limb ischemia, major amputation due to vascular disease
Time frame: The 9th month after treatment
The incidence of myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation owing to vascular disease after the treatment. Measured in the first, sixth, ninth, and twelfth month.
Composite adverse event incidence (MACE/MALE) : myocardial infarction, ischemic stroke, acute limb ischemia, major amputation due to vascular disease
Time frame: The 12th month after treatment
The incidence of myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation owing to vascular disease after the treatment. Measured in the first, sixth, ninth, and twelfth month.
5 secondary outcomes
MACE
Time frame: The 1st，3rd，6th，9th，12th month
MALE
Time frame: The 1st，3rd，6th，9th，12th month
Compound protection from vasogenic adverse events
Time frame: The 1st，3rd，6th，9th，12th month
all-cause mortality
Time frame: The 1st，3rd，6th，9th，12th month
health economics evaluation
Time frame: The 1st，3rd，6th，9th，12th month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: Yes. With the consent of the committee, it can be based on patient data
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anticoagulant Drugs and Antiplatelet Drug, run by First Affiliated Hospital of Zhejiang University 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 5 inclusion and 3 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 10 May 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite adverse event incidence (MACE/MALE) : myocardial infarction, ischemic stroke, acute limb ischemia, major amputation due to vascular disease (time frame: The 1st month after treatment). The study lists 5 primary outcomes in all. 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 10 May 2023.