Helping people who have had heart stents who are having surgeries that aren't related to the heart, using Perioperative Bridging Therapy
| ISRCTN | ISRCTN65203415 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65203415 |
| Secondary identifying numbers | Funding No. 2022YFC3602405, Funding No. NCRCG-PLAGH-2023003 |
- Submission date
- 08/12/2023
- Registration date
- 12/12/2023
- Last edited
- 24/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Not much information is available about the safety of using low-molecular-weight heparin (LMWH) as a bridging therapy for surgery performed more than 12 months after stent implantation. The randomized trial was set up to assess and compare the positive and negative effects of stopping antiplatelet drugs while using LMWH bridging therapy.
Who can participate?
Patients aged 75 years or older, who had a heart stent in the last 12 months, received antiplatelet therapy for 1 year or longer, and were undergoing elective surgery or other elective invasive procedure that required interruption of antiplatelet therapy
What does the study involve?
Patients were randomly assigned in equal numbers to receive either subcutaneous injections of dalteparin sodium or a placebo. The main goal was to measure the effectiveness by looking at cardiac or cerebrovascular events. The main focus on safety was to observe major bleeding.
What are the possible benefits and risks of participating?
Where is the study run from?
Chinese PLA General Hospital (China)
When is the study starting and how long is it expected to run for?
January 2022 to December 2024
Who is funding the study?
This study was supported by the “National Key R&D Program of China” (Funding No. 2022YFC3602405), co-funded by the National Clinical Research Center for Geriatric Diseases projects (Funding No. NCRCG-PLAGH-2023003).
Who is the main contact?
Prof Linggen Gao, gaolinggen@163.com
Contact information
Public, Scientific, Principal Investigator
Fuxing Road 28
Beijing
100853
China
| Phone | +86 15801612879 |
|---|---|
| chenleighcpl@163.com |
Study information
| Study design | Randomized placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, Medical and other records |
| Study type | Treatment, Safety, Efficacy |
| Scientific title | Impact of Perioperative Bridging Therapy on clinical events of elderly patients with prior coronary stents implanted >1 year undergoing non-cardiac surgery |
| Study acronym | IPBT |
| Study objectives | The safety of with low-molecular-weight heparin (LMWH) bridging therapy surgery performed >12 months from stents implantation. |
| Ethics approval(s) |
Approved 31/01/2022, Ethics Committee Of Chinese PLA General Hosptial (Fuxing Road, Beijing, 100853, China; +86 10-66937166; no.email.provided@a), ref: S2022-664-03 |
| Health condition(s) or problem(s) studied | Clinical benefits and risks of discontinuing antiplatelet drugs with LMWH bridging therapy in patients with coronary stents undergoing noncardiac surgery |
| Intervention | Patients were randomly assigned using an online tool to receive LMWH bridging therapy with dalteparin sodium (2500 IU administered subcutaneously twice daily) or to receive no bridging therapy (a matching subcutaneous placebo). All study outcomes were assessed 30 days after the procedure. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Dose response |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | dalteparin sodium |
| Primary outcome measure | Primary efficacy outcome: Composite of major adverse cardiac or cerebrovascular events, defined as myocardial injury, myocardial infarction, cardiac death and non-fatal stroke measured using patient records at the end of the study Primary safety outcome: Major bleeding defined by one or more of the events defined by the International Society on Thrombosis and Haemostasis measured using patient records at the end of the study |
| Secondary outcome measures | Secondary efficacy outcomes: Pulmonary embolism, deep-vein thrombosis and death measured using patient records at the end of the study Secondary safety outcome: Minor bleeding measured using patient records at the end of the study |
| Overall study start date | 31/01/2022 |
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 75 Years |
| Sex | Both |
| Target number of participants | 2,500 |
| Total final enrolment | 2476 |
| Key inclusion criteria | 1. 75 years of age or older 2. Underwent PCI with stents >12 months 3. Had received antiplatelet therapy for 1 year or longer 4. Were undergoing elective surgery or other elective invasive procedure that required interruption of antiplatelet therapy |
| Key exclusion criteria | 1. Less than 75 years of age 2. Have taken antiplatelet therapy for less than 12 months 3. Were scheduled for local anesthesia surgery, planned cardiac surgery 4. Major cardiac ischemic events and/or bleeding within the previous 6 weeks 5. Patients with a mechanical heart valve, some of whom were receiving both oral anticoagulant therapy and antiplatelet therapy 6. Platelet count of less than 100×1^3 per cubic millimeter. |
| Date of first enrolment | 01/01/2023 |
| Date of final enrolment | 01/11/2023 |
Locations
Countries of recruitment
- China
Study participating centre
Beijing
100853
China
Sponsor information
Hospital/treatment centre
Fuxing Road
Beijing
100853
China
| Phone | +86 15801612879 |
|---|---|
| gaolinggen@163.com | |
| Website | http://www.301hospital.com.cn/en2012/web/Introduction.html |
"ROR" |
https://ror.org/04gw3ra78 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- 重点基础研究发展计划, National Basic Research Program of China (973 Program), Special Fund for the National Key Research and Development Plan, China National Key Research and Development Plan Project, National Key Research and Development of China, National Key Research and Development Program, National Key R&D Program of China, National Key R&D Programmes of China, China's National Key R&D Programmes, National Basic Research Program of China, 973 Program, National Program on Key Basic Research Project (973 Program), National Plan on Key Basic Research and Development, National Basic Research Program, NKRDPC, NKPs
- Location
- China
No information available
Results and Publications
| Intention to publish date | 31/01/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Planned published in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during hte current study will be stored in a non-publicly available repository. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 23/04/2024 | 24/04/2024 | Yes | No |
Editorial Notes
24/04/2024: Publication reference added.
11/12/2023: Trial's existence confirmed by NMPIED
