PCI PatientsNCT07024446
Comparison of Cardiovascular Risks Between Hip Fracture Surgery With Continued DAPT(Dual Antiplatelet Therapy ) Within 6 Weeks vs After 6 Weeks Post-PCI(Percutaneous Coronary Intervention): A Prospective Observational Cohort Study
An observational study of PCI Patients and DAPT(Dual Antiplatelet Therapy), run by Fujian Medical University Union Hospital.
Trial summary
Percutaneous coronary intervention (PCI) is commonly used to treat stable ischemic heart disease. Among patients, 7.5% require surgical treatment, and up to 20% may need noncardiac surgery (NCS) within two years. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- PCI Patients, DAPT(Dual Antiplatelet Therapy), Hip Fracture Surgeries
- What is being tested?
- The time interval between PCI and NCS
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stable coronary artery disease undergoing hip fracture surgery after PCI were divided into two groups: 25 cases in the surgery group within 6 weeks after PCI (observation group) and 25 cases in the surgery group after 6 weeks post-PCI (control group).
Who may be able to join
- Normal hs-cTnI levels prior to NCS BMI 20-28 kg/m² Post-PCI procedure, currently on regular DAPT therapy Complete PCI procedural documentation (date, quantity, stent type) Mentally sound, capable of normal communication
Who cannot join
- Abnormal hs-cTnI before NCS; Accompanied by dysfunction of other organs History of other major surgeries Risk factors for stent thrombosis (age >79 years, impaired left ventricular function, stent implantation due to acute coronary syndrome, multiple stents, diabetes, renal insufficiency with creatinine >1.5 mg/dl) Abnormal coagulation function Local anesthesia surgery Inability to cooperate
About this study
Official title: Comparison of Cardiovascular Risks Between Hip Fracture Surgery With Continued (Dual Antiplatelet Therapy ) Within 6 Weeks vs After 6 Weeks Post-(Percutaneous Coronary Intervention): A Prospective Observational Cohort Study
Percutaneous coronary intervention (PCI) is commonly used to treat stable ischemic heart disease. Among patients, 7.5% require surgical treatment, and up to 20% may need noncardiac surgery (NCS) within two years.
Compared to patients without coronary stents, those requiring NCS shortly after PCI face an increased risk of perioperative major adverse cardiac and cerebrovascular events (MACCE), primarily manifested as thrombotic and bleeding events. Guidelines recommend 6-12 months of dual antiplatelet therapy (DAPT) post-PCI to prevent stent thrombosis, which is associated with an elevated risk of perioperative bleeding during NCS. Multiple retrospective studies suggest that the incidence of MACCE decreases as the interval between PCI and NCS lengthens, reaching a risk level similar to non-PCI patients after 12 months. However, other studies indicate that the risk in patients with similar PCI-NCS intervals correlates more with surgical complexity and urgency. Guidelines advise adequate antiplatelet therapy post-PCI to prevent stent thrombosis and recommend avoiding elective surgery within 4-6 weeks after PCI, contingent on bleeding and thrombotic risk assessments.
Read more
Many post-PCI patients facing NCS option to delay surgery after weighing the risks of discontinuing antiplatelet therapy versus postponement, which not only reduces quality of life but also increases the risks associated with delayed surgery. Additionally, retrospective studies have found that in unavoidable emergency or time-sensitive surgeries, the heightened perioperative cardiovascular risk is primarily due to the underlying surgical condition affecting organ function, rather than the PCI-NCS interval or antiplatelet therapy discontinuation.
Recent advancements in minimally invasive surgical techniques have reduced trauma and bleeding, leading to broader indications for surgery in patients on anticoagulant or antiplatelet therapy. The widespread use of newer-generation drug-eluting stents (DES) with advanced antiproliferative drugs has further lowered stent thrombosis rates. Moreover, refined PCI techniques minimize vascular injury during stent placement, reducing the likelihood of extra-stent restenosis. From an anesthesiology perspective, concerns for post-PCI surgical patients extend beyond bleeding risks to whether cardiac function can withstand perioperative hemodynamic changes. As surgical and anesthetic techniques evolve, traditional single-method anesthesia is increasingly replaced by combined techniques that ensure adequate analgesia while minimizing hemodynamic disturbances, maintaining oxygen supply-demand balance, and reducing ischemic and bleeding events.
Hip fractures in elderly patients, often termed the "last fracture in life," carry high surgical and anesthetic risks for those with coronary artery disease. While PCI addresses coronary stenosis, the use or discontinuation of antiplatelet therapy exposes patients to bleeding and ischemic risks. The optimal timing for hip fracture surgery is within 48 hours; delays may lead to malunion, prolonged bedrest complications (e.g., pressure sores, pneumonia), and increased deep vein thrombosis risk. Modern hip fracture surgeries (e.g., internal fixation, hip replacement, Proximal femoral nail antirotation internal fixation) are well-established, with reduced bleeding and faster recovery, making it feasible to perform surgery without interrupting antiplatelet therapy.
Existing research primarily consists of retrospective analyses of cardiovascular risk prediction in post-PCI patients undergoing NCS, with no recent prospective studies. Guideline recommendations on PCI-NCS intervals remain unchanged since 2016. Consequently, many PCI patients must delay surgery, enduring unpredictable risks and diminished quality of life.
This study aims to prospectively observe the incidence of MACCE in hip fracture surgery performed within six weeks post-PCI without discontinuing DAPT. The findings may provide evidence for the feasibility of early post-PCI surgery, offer clinicians and patients safer antithrombotic strategies, and present a new option to improve patient quality of life.
- Being tested
- The time interval between PCI and NCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The time interval between PCI and NCSOther
Using 6 weeks post-PCI as the demarcation point, patients within 6 weeks were assigned to the observation group, while those beyond 6 weeks formed the control group.
| Study group | Role | What they receive |
|---|---|---|
| Observation group | Within 6 weeks after PCI Receives: Other: The time interval between PCI and NCS | |
| Control group | beyond 6 weeks after PCI Receives: Other: The time interval between PCI and NCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative changes in blood High-sensitivity cardiac troponin I (hs-cTnI) levels
Detection using chemiluminescence immunoassay (CLIA)
Measured: From admission to discharge
Electrocardiogram ST-T changes
Measured: From admission to discharge
Perioperative surgical site blood loss
Including intraoperative blood drainage volume, gauze usage, and postoperative wound bleeding drainage volume
Measured: Perioperative period
Occurrence of Perioperative Adverse Events and Patient Self-Reported Symptoms
Measured: From admission to discharge
Secondary outcomes (3)
Changes in blood hs-cTnI levels
Detection using chemiluminescence immunoassay (CLIA)
Measured: Once a month within six months after discharge.
Electrocardiogram ST-T changes
Measured: Once a month within six months after discharge
Occurrence of Perioperative Adverse Events and Patient Self-Reported Symptoms
Measured: Half a year after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCI PatientsStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024446
- Sponsor's protocol ID
- Continued DAPT after PCI
- Status last verified
- May 2025
- First submitted
- 29 May 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cardiovascular Risks Between Hip Fracture Surgery With Continued (Dual Antiplatelet Therapy ) Within 6 Weeks vs After 6 Weeks Post-(Percutaneous Coronary Intervention): A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07024446
- Acronym / sponsor ID
- Continued DAPT after PCI
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 17 Jun 2025 (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.
Percutaneous coronary intervention (PCI) is commonly used to treat stable ischemic heart disease. Among patients, 7.5% require surgical treatment, and up to 20% may need noncardiac surgery (NCS) within two years.
Compared to patients without coronary stents, those requiring NCS shortly after PCI face an increased risk of perioperative major adverse cardiac and cerebrovascular events (MACCE), primarily manifested as thrombotic and bleeding events. Guidelines recommend 6-12 months of dual antiplatelet therapy (DAPT) post-PCI to prevent stent thrombosis, which is associated with an elevated risk of perioperative bleeding during NCS. Multiple retrospective studies suggest that the incidence of MACCE decreases as the interval between PCI and NCS lengthens, reaching a risk level similar to non-PCI patients after 12 months. However, other studies indicate that the risk in patients with similar PCI-NCS intervals correlates more with surgical complexity and urgency. Guidelines advise adequate antiplatelet therapy post-PCI to prevent stent thrombosis and recommend avoiding elective surgery within 4-6 weeks after PCI, contingent on bleeding and thrombotic risk assessments.
Many post-PCI patients facing NCS option to delay surgery after weighing the risks of discontinuing antiplatelet therapy versus postponement, which not only reduces quality of life but also increases the risks associated with delayed surgery. Additionally, retrospective studies have found that in unavoidable emergency or time-sensitive surgeries, the heightened perioperative cardiovascular risk is primarily due to the underlying surgical condition affecting organ function, rather than the PCI-NCS interval or antiplatelet therapy discontinuation.
Recent advancements in minimally invasive surgical techniques have reduced trauma and bleeding, leading to broader indications for surgery in patients on anticoagulant or antiplatelet therapy. The widespread use of newer-generation drug-eluting stents (DES) with advanced antiproliferative drugs has further lowered stent thrombosis rates. Moreover, refined PCI techniques minimize vascular injury during stent placement, reducing the likelihood of extra-stent restenosis. From an anesthesiology perspective, concerns for post-PCI surgical patients extend beyond bleeding risks to whether cardiac function can withstand perioperative hemodynamic changes. As surgical and anesthetic techniques evolve, traditional single-method anesthesia is increasingly replaced by combined techniques that ensure adequate analgesia while minimizing hemodynamic disturbances, maintaining oxygen supply-demand balance, and reducing ischemic and bleeding events.
Hip fractures in elderly patients, often termed the "last fracture in life," carry high surgical and anesthetic risks for those with coronary artery disease. While PCI addresses coronary stenosis, the use or discontinuation of antiplatelet therapy exposes patients to bleeding and ischemic risks. The optimal timing for hip fracture surgery is within 48 hours; delays may lead to malunion, prolonged bedrest complications (e.g., pressure sores, pneumonia), and increased deep vein thrombosis risk. Modern hip fracture surgeries (e.g., internal fixation, hip replacement, Proximal femoral nail antirotation internal fixation) are well-established, with reduced bleeding and faster recovery, making it feasible to perform surgery without interrupting antiplatelet therapy.
Existing research primarily consists of retrospective analyses of cardiovascular risk prediction in post-PCI patients undergoing NCS, with no recent prospective studies. Guideline recommendations on PCI-NCS intervals remain unchanged since 2016. Consequently, many PCI patients must delay surgery, enduring unpredictable risks and diminished quality of life.
This study aims to prospectively observe the incidence of MACCE in hip fracture surgery performed within six weeks post-PCI without discontinuing DAPT. The findings may provide evidence for the feasibility of early post-PCI surgery, offer clinicians and patients safer antithrombotic strategies, and present a new option to improve patient quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation group | – | Other: The time interval between PCI and NCSWithin 6 weeks after PCI |
| Control group | – | Other: The time interval between PCI and NCSbeyond 6 weeks after PCI |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stable coronary artery disease undergoing hip fracture surgery after PCI were divided into two groups: 25 cases in the surgery group within 6 weeks after PCI (observation group) and 25 cases in the surgery group after 6 weeks post-PCI (control group).
Key inclusion criteria (1 listed)
- Normal hs-cTnI levels prior to NCS BMI 20-28 kg/m² Post-PCI procedure, currently on regular DAPT therapy Complete PCI procedural documentation (date, quantity, stent type) Mentally sound, capable of normal communication
Key exclusion criteria (1 listed)
- Abnormal hs-cTnI before NCS; Accompanied by dysfunction of other organs History of other major surgeries Risk factors for stent thrombosis (age >79 years, impaired left ventricular function, stent implantation due to acute coronary syndrome, multiple stents, diabetes, renal insufficiency with creatinine >1.5 mg/dl) Abnormal coagulation function Local anesthesia surgery Inability to cooperate
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 |
|---|---|---|
| The time interval between PCI and NCSUsing 6 weeks post-PCI as the demarcation point, patients within 6 weeks were assigned to the observation group, while those beyond 6 weeks formed the control group. | Other | Control group, Observation group |
Primary outcome
Perioperative changes in blood High-sensitivity cardiac troponin I (hs-cTnI) levels
Time frame: From admission to discharge
Detection using chemiluminescence immunoassay (CLIA)
Electrocardiogram ST-T changes
Time frame: From admission to discharge
Perioperative surgical site blood loss
Time frame: Perioperative period
Including intraoperative blood drainage volume, gauze usage, and postoperative wound bleeding drainage volume
Occurrence of Perioperative Adverse Events and Patient Self-Reported Symptoms
Time frame: From admission to discharge
3 secondary outcomes
Changes in blood hs-cTnI levels
Time frame: Once a month within six months after discharge.
Electrocardiogram ST-T changes
Time frame: Once a month within six months after discharge
Occurrence of Perioperative Adverse Events and Patient Self-Reported Symptoms
Time frame: Half a year after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
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Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of PCI Patients and DAPT(Dual Antiplatelet Therapy), run by Fujian Medical University Union Hospital.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Perioperative changes in blood High-sensitivity cardiac troponin I (hs-cTnI) levels (time frame: From admission to discharge). The study lists 4 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 17 Jun 2025.