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
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Funding No. 2022YFC3602405, Funding No. NCRCG-PLAGH-2023003
Sponsor	Chinese PLA General Hospital
Funders	National Key Research and Development Program of China, National Clinical Research Center for Geriatric Diseases

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Prof Linggen Gao
Public, Scientific, Principal investigator

Fuxing Road 28
Beijing
100853
China

Phone	+86 15801612879
Email	chenleighcpl@163.com

Study information

Primary study design	Interventional
Study design	Randomized placebo-controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	dalteparin sodium
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	31/12/2024

Eligibility

Participant type(s)	Patient
Age group	Senior
Lower age limit	75 Years
Sex	All
Target sample size at registration	2500
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

Chinese PLA General Hospital

Fuxing Road 28
Beijing
100853
China

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in non-publicly available repository
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