Coronary Artery DiseaseSAFENCT04675801
SAfety and EFficacy of Bridging Antithrombotic Therapy During Elective Non-cardiac Surgery
An observational study of Coronary Artery Disease, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
Patients with coronary artery disease, especially after PCI, require long-term oral antiplatelet therapy. However, this patient population may inevitably require non-cardiac surgery for a variety of conditions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- Type of treatment
- Pill or oral medicine
- How many people
- 950 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2021to Jun 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Coronary artery disease patients treated with oral antiplatelet therapy are planned to undergo non-cardiac surgery with high or extremely high surgical bleeding risk
Who may be able to join
- Aged 18 years or over
- Established coronary artery disease being treated with oral antiplatelet therapy
- Non-cardiac surgery is planned and bridging antithrombotic therapy is considered necessary
- Agree to participate in the study and provide written informed consent
Who cannot join
- According to the consensus of Chinese experts on antiplatelet therapy in 2013, the surgical bleeding risk is low or extremely low
- Requiring emergency non-cardiac surgery within 24 hours after admission
- Currently being bleeding
- Moderate or severe ischemic stroke or spontaneous intracranial hemorrhage in the past 6 months or traumatic intracranial hemorrhage in the past 1 year
- Intracranial diseases or hemorrhagic diathesis
- Contraindications for LMWH or GP IIb/IIIa receptor antagonists
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
Xiaoli Liu, PhD, MD, 8613581633895, liuxl9881@163.com
Xiaoteng Ma, PhD, MD, 8618810616459, maxiaotengai@163.com
About this study
Official title: Safety and Efficacy of Bridging Antithrombotic Therapy During Elective Non-cardiac Surgery for Coronary Artery Disease Patients Treated With Oral Antiplatelet Agents
Patients with coronary artery disease, especially after PCI, require long-term oral antiplatelet therapy. However, this patient population may inevitably require non-cardiac surgery for a variety of conditions. In order to avoid the occurrence of bleeding events, oral antiplatelet agents are usually discontinued before non-cardiac surgery in patients with coronary artery disease, which may increase the incidence of ischemic events. Therefore, it is important to provide patients with the optimal perioperative antithrombotic treatment to balance the risk of bleeding and ischemia.
- Conditions
- Coronary Artery Disease
- Keywords
- Bridging antithrombotic therapy, Non-cardiac surgery, coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bridging therapy with LMWH (n=475) | Bridging therapy with LMWH was performed after discontinuation of oral antiplatelet agents prior to non-cardiac surgery | |
| Bridging therapy with tirofiban (n=475) | Bridging therapy with tirofiban was performed after discontinuation of oral antiplatelet agents prior to non-cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events
A composite of all-cause death, non-fatal myocardial infarction, or non-fatal stroke
Measured: Perioperative period
Secondary outcomes (3)
TIMI major or minor bleeding
A composite of major or minor bleeding events as defined by the TIMI bleeding criteria
Measured: Perioperative period
Net adverse clinical events
A composite of major adverse cardiovascular events and TIMI major or minor bleeding
Measured: Perioperative period
Net adverse clinical events
A composite of major adverse cardiovascular events and TIMI major or minor bleeding
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start2 Mar 2021
- Primary completionApr 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe 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
- 950 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yujie Zhou, Beijing Anzhen Hospital
- Investigators
- Xiaoli Liu, PhD, MD, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04675801
- Sponsor's protocol ID
- SAFE
- Acronym
- SAFE
- Status last verified
- Nov 2021
- First submitted
- 15 Dec 2020
- Last updated
- 11 Nov 2021
- 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 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Bridging Antithrombotic Therapy During Elective Non-cardiac Surgery for Coronary Artery Disease Patients Treated With Oral Antiplatelet Agents
- ClinicalTrials.gov ID
- NCT04675801
- Acronym / sponsor ID
- SAFE / SAFE
- Conditions
- Coronary Artery Disease
- Keywords
- Bridging antithrombotic therapy, Non-cardiac surgery, coronary artery disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 950 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 19 Dec 2020 (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 coronary artery disease, especially after PCI, require long-term oral antiplatelet therapy. However, this patient population may inevitably require non-cardiac surgery for a variety of conditions. In order to avoid the occurrence of bleeding events, oral antiplatelet agents are usually discontinued before non-cardiac surgery in patients with coronary artery disease, which may increase the incidence of ischemic events. Therefore, it is important to provide patients with the optimal perioperative antithrombotic treatment to balance the risk of bleeding and ischemia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bridging therapy with LMWH (n=475) | – | –Bridging therapy with LMWH was performed after discontinuation of oral antiplatelet agents prior to non-cardiac surgery |
| Bridging therapy with tirofiban (n=475) | – | –Bridging therapy with tirofiban was performed after discontinuation of oral antiplatelet agents prior to non-cardiac surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Coronary artery disease patients treated with oral antiplatelet therapy are planned to undergo non-cardiac surgery with high or extremely high surgical bleeding risk
Key inclusion criteria (4 listed)
- Aged 18 years or over
- Established coronary artery disease being treated with oral antiplatelet therapy
- Non-cardiac surgery is planned and bridging antithrombotic therapy is considered necessary
- Agree to participate in the study and provide written informed consent
Key exclusion criteria (6 listed)
- According to the consensus of Chinese experts on antiplatelet therapy in 2013, the surgical bleeding risk is low or extremely low
- Requiring emergency non-cardiac surgery within 24 hours after admission
- Currently being bleeding
- Moderate or severe ischemic stroke or spontaneous intracranial hemorrhage in the past 6 months or traumatic intracranial hemorrhage in the past 1 year
- Intracranial diseases or hemorrhagic diathesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major adverse cardiovascular events
Time frame: Perioperative period
A composite of all-cause death, non-fatal myocardial infarction, or non-fatal stroke
3 secondary outcomes
TIMI major or minor bleeding
Time frame: Perioperative period
Net adverse clinical events
Time frame: Perioperative period
Net adverse clinical events
Time frame: 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- 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.
Xiaoli Liu, PhD, MD principal investigator
Beijing Anzhen Hospital
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 Coronary Artery Disease, run by Beijing Anzhen Hospital 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 6 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 11 Nov 2021. 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?
Contact Xiaoli Liu, PhD, MD (8613581633895, liuxl9881@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular events (time frame: Perioperative period). 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 11 Nov 2021.