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| Name | Class |
|---|---|
| People's Hospital of Xinjiang Uygur Autonomous Region | OTHER |
| LanZhou University | OTHER |
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This is a prospective, multi-center, randomized controlled, open-label, blinded endpoint assessment study. The objective is to compare the 1-year incidence of major adverse cardiovascular and cerebrovascular events (MACCE) between two treatment strategies-immediate complete revascularization and staged complete revascularization-in NSTE-ACS patients with multivessel disease (MVD).
NSTE-ACS patients who meet other the inclusion and exclusion criteria will be randomized into the following two groups after signing an informed consent form:
Intervention group Immediate Complete Revascularization: Emergency PCI for the culprit vessel is performed successfully, and simultaneous PCI is conducted for non-culprit vessels that meet the defined criteria (visually estimated diameter ≥2.5 mm, eligible for successful PCI, and visually estimated maximum diameter stenosis ≥ 70% or positive coronary physiology testing).
Control group During emergency intervention, PCI is performed only on the culprit vessel. Elective PCI is then conducted for non-culprit vessels that meet the defined criteria (visually estimated diameter ≥ 2.5 mm, eligible for successful PCI, and visually estimated maximum diameter stenosis ≥ 70% or positive coronary physiology testing)-either during the current emergency hospitalization or within 6 weeks after the culprit vessel PCI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Complete Revascularization | Experimental |
| |
| Staged Complete Revascularization | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate Complete Revascularization | Device | Immediate Complete Revascularization: Emergency PCI for the culprit vessel is performed successfully, and simultaneous PCI is conducted for non-culprit vessels that meet the defined criteria (visually estimated diameter ≥2.5 mm, eligible for successful PCI, and visually estimated maximum diameter stenosis ≥ 70% or positive coronary physiology testing). |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiovascular and cerebrovascular event (MACCE) | defined as a composite of all-cause death, non-fatal myocardial infarction, unplanned ischemia-driven revascularization, and stroke | at 1 year after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiovascular and cerebrovascular event (MACCE) | defined as a composite of all-cause death, non-fatal myocardial infarction, unplanned ischemia-driven revascularization, and stroke | 1 month, 6 months, 2 years, 3 years after randomization |
| All-cause death |
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Inclusion Criteria:
Exclusion Criteria:
Have received thrombolytic treatment.
Cardiogenic shock or SBP< 90 mmHg.
Patients in whom the culprit vessel cannot be clearly identified.
Left main coronary artery lesion, non-infarct-related arteries are CTO lesions or severely calcified lesions, complex lesions that require the use of special devices such as rotational ablation/laser.
Previous PCI within the past 1 month or previous coronary artery bypass graft (CABG).
Accompanied by other diseases that lead to an expected survival time of ≤ 12 months.
Patients with other serious diseases such as severe renal insufficiency (creatinine clearance value <30ml/min), hepatic insufficiency, thrombocytopenia (≤50*109/L).
Patients with severe valvular disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, and primary pulmonary hypertension.
Not suitable for clinical study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Pu, MD, PhD | Contact | 86-21-68383477 | pujun310@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun Pu, MD, PhD | RenJi Hospital | Principal Investigator |
| Yining Yang, MD, PhD | People's Hospital of Xinjiang Uygur Autonomous Region | Principal Investigator |
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Bona fide researchers can request access to the data after the publication of the main results, provided that a study protocol is submitted to and approved by the FUTURE II Steering Committee.
Data sharing will be available from 12 months after the publication of the main results.
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|
| Staged Complete Revascularization | Device | During emergency intervention, PCI is performed only on the culprit vessel. Elective PCI is then conducted for non-culprit vessels that meet the defined criteria (visually estimated diameter ≥ 2.5 mm, eligible for successful PCI, and visually estimated maximum diameter stenosis ≥ 70% or positive coronary physiology testing)-either during the current emergency hospitalization or within 6 weeks after the culprit vessel PCI. |
|
cardiovascular, non-cardiovascular, death of undetermined cause |
| 1 month, 6 months, 1 year, 2 years, 3 years after randomization |
| Cardiac death | 1 month, 6 months, 1 year, 2 years, 3 years after randomization |
| Myocardial infarction | target vessel related, non-target vessel related | 1 month, 6 months, 1 year, 2 years, 3 years after randomization |
| Target vessel revascularization | ischemia-driven, non-ischemia-driven | 1 month, 6 months, 1 year, 2 years, 3 years after randomization |
| Any coronary revascularization | ischemia-driven, non-ischemia-driven | 1 month, 6 months, 1 year, 2 years, 3 years after randomization |
| ARC-2 defined stent thrombosis | including confirmed and possible stent thrombosis in acute, subacute, and late time frames | 1 month, 6 months, 1 year, 2 years, 3 years after randomization |
| Stroke | ischaemia, hemorrhage | 1 month, 6 months, 1 year, 2 years, 3 years after randomization |
| Contrast agent-related acute kidney injury | 1 month after randomization |
| Major bleeding | BARC grades 3 and 5 | 1 month, 6 months, 1 year, 2 years, 3 years after randomization |
| Ming Bai, MD, PhD |
| LanZhou University |
| Principal Investigator |
| ID | Term |
|---|---|
| D000072658 | Non-ST Elevated Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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