AzTrials
AzTrials

STEMISAGEDNCT04918030

STaged Interventional Strategies for Acute ST-seGment Elevation Myocardial Infarction Patient With Multi-vessel Disease（STAGED）

A study testing Early staged PCI and Late staged PCI in people with STEMI and Multi Vessel Coronary Artery Disease, run by Xiamen Cardiovascular Hospital, Xiamen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

An investigator-initiated, randomized, multicenter, two-arm, open-label study of consecutive patients presenting with STEMI and MVD Objectives: The present study aimed to investigate the difference in major adverse cardiac event (MACE) between Early staged PCI versus Late staged PCI groups among patients with… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Early staged PCI and Late staged PCI
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,586 participants
Where
1 siteChina
Study dates
11 Feb 2021to 1 Feb 2025
Phase
Interventional
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provision of informed consent prior to any study specific procedures;
  • Established indication to PPCI according to the guidelines of American Heart Association and American College of Cardiology;
  • Spontaneous acute STEMI (patients presenting within 24 hours of symptom onset) with MVD after successful revascularization of the culprit artery;
  • De novo coronary lesion,
  • TIMI Flow 3 ( Cases with TIMI flow 2 need to perform angiographic again in 24h ensured TIMI flow 3 for enrolling case )after revascularization of the culprit artery, residual stenosis ≤20% and no coronary dissection greater than or equal to type C leading to (threatening) vessel closure.
  • At least one non-culprit coronary stenosis ≥ 80% and accompanied by QFR ≤0.8 in a vessel with a lumen diameter ≥2.5;

Who cannot join

  • Age <18 yr and >80 yr;
  • Cardiac shock, multiple organ failure, cerebral hemorrhage, severe aortic stenosis and myocardial infarction complications(cardiac rupture, ventricular septal rupture and papillary muscle rupture);
  • Killip classification >3, cardiognic shock, shore-infarction of culprit artery after emergency PCI in 24 hours;
  • Previous documented allergic reaction to drug and device of this study;
  • Planned major surgery within 6 weeks in which impact DAPT;
  • Participation in another clinical study, interfering with this protocol Uncertain;
  • Life expectancy < 1 year;
  • Any condition likely to interfere with study processes including follow-up visits or increase of risk accessed by researcher.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xiamen Cardiovascular Hospital Xiamen University

    Xiamen, Fujian, 361000

Other trials in China

About this study

Official title: STaged Interventional Strategies for Acute ST-seGment Elevation Myocardial Infarction Patient With Multi-vessel Disease （STAGED）

An investigator-initiated, randomized, multicenter, two-arm, open-label study of consecutive patients presenting with STEMI and MVD Objectives: The present study aimed to investigate the difference in major adverse cardiac event (MACE) between Early staged PCI versus Late staged PCI groups among patients with ST-segment elevated myocardial infarction （STEMI and multi-vessel Disease（MVD) who underwent primary PCI using DES for culprit lesions.

Background: In patients with STEMI with MVD who underwent primary PCI, complete revascularization for non-culprit lesions has proved to reduce the risk of cardiovascular death and myocardial infarction. However, the ideal timing point for staged PCI for nonculprit lesions remains uncertain.

Read the detailed description

A total of 1586 subjects with STEMI who met inclusion criteria and had no any exclusion criterion will be randomized (at a 1:1 ratio) to Early staged PCI group and Late staged PCI group. After successful percutaneous coronary intervention for culprit lesion, staged PCI for all non-culprit vessel with significant lesion defined at least 80% diameter stenosis by visual estimation and accompanied by a QFR measurement of less than or equal to 0.80 will be performed. Patients will be ranmized to the following groups at 1:1 ratio:

  1. Patients randomized to the in-hospital staged PCI (Early group) will undergo PCI for all significant non-culprit lesions at 7±3 days after revascularization of the culprit lesion.
  2. Patients randomized to out-hospital staged complete revascularization (Late group) will undergo PCI for all significant non-culprit lesions at 30±15 days after primary PCI.
Being tested
Early staged PCI, Late staged PCI
Keywords
AMI, multivessel disease, PCI, staged complete revascularization
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early staged PCIProcedure or surgery

    Also called Percutaneous coronary intervention

    After revascularization of the culprit lesion, all significant non-culprit vessel will be complete revascularzed during index the index procedure (7±3 day).

  • Late staged PCIProcedure or surgery

    Also called Percutaneous coronary intervention

    During the index procedure, patients will have treated with primary PCI the culprit lesion only. Patients will be hospitalized again after 30±15 days to undergo PCI of the other significant coronary lesions.

Study groups in NCT04918030
Study groupRoleWhat they receive
Early staged groupActive comparatorPatients randomized to Early group will undergo staged PCI for all significant non-culprit lesions at 7±3 days after revascularization of the culprit lesion.
Receives: Procedure: Early staged PCI
Late staged PCIExperimentalPatients randomized to Late Group will undergo staged PCI for all significant non-culprit lesion at 30±15 days after primary PCI for culprit coronary lesions.
Receives: Procedure: Late staged PCI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major adverse cardiac event (MACE), defined as cardiovascular death, MI, ischemia-driven revasculrization (for both culprit and non-culprit lesions).

    The difference in MACE will be calculated from randomisation to 12 months.

    Measured: 12 months

Secondary outcomes (7)

  1. All-cause death

    It will be calculated from randomisation to 12 months.

    Measured: 12 months

  2. Myocardial Infarction (MI)

    It will be calculated and compared from randomisation to 12 months Periprocedural MI (PMI): Defined as a CK-MB elevation greater than 10 times the upper reference limit (URL) within 72 hours post-procedure, in the absence of symptoms or ECG changes. If the patient presented with ischemic symptoms, ischemic ECG changes, or intra-procedural slow-flow or side-branch occlusion, PMI is defined as a CK-MB elevation greater than 5 times the URL.

    Spontaneous MI: Defined as a rise of cardiac biomarkers, preferably cardiac troponin (cTn), with at least one value above the 99th percentile URL, accompanied by at least one of the following: ischemic symptoms, new ischemic ECG changes (including new ST-T changes or new left bundle branch block), development of pathological Q waves, or imaging evidence of new regional wall motion abnormalities or loss of viable myocardium.

    Measured: 12 months

  3. Revascularization

    Ischemia-driven Coronary Revascularization Ischemia-driven coronary revascularization was defined in accordance with the Academic Research Consortium-2 (ARC-2) consensus. In this study, ischemia-driven coronary revascularization included any repeat percutaneous coronary intervention or coronary artery bypass grafting performed due to myocardial ischemia, irrespective of whether the lesion was located in a target or non-target vessel. Following the ARC-2 criteria, revascularization was considered ischemia-driven if it was associated with objective evidence of myocardial ischemia, including recurrent ischemic symptoms, ischemic changes on electrocardiogram, positive results from non-invasive stress testing, or fractional flow reserve less than or equal to 0.80. When functional assessment was not available, adjudication by the Clinical Events Committee using independent quantitative coronary angiography of baseline and repeat angiograms was required.

    Measured: 12 months

  4. Cardiovascular death

    Cardiovascular death includes sudden cardiac death, death due to acute myocardial infarction, heart failure, cerebrovascular events, other cardiovascular causes, such as pulmonary embolism, aortic disease, or complications arising from cardiovascular interventions or surgeries.

    Measured: 12 months

  5. Heart failure-induced rehospitalization

    Rate of New hospitalization for heart failure

    Measured: 12 months

  6. Stroke

    According to the 2013 AHA/ASA guidelines, stroke is defined as cerebral infarction, intracerebral hemorrhage (ICH), or subarachnoid hemorrhage (SAH), all characterized by acute, focal dysfunction of the central nervous system (CNS) resulting from vascular causes.

    Measured: 12month

  7. Rate of contrast-induced nephropathy（CIN）

    Contrast-Induced Nephropathy (Based on KDIGO criteria)

    1. An increase in serum creatinine to ≥1.5 times the baseline value within 7 days following exposure to contrast media.
    2. An absolute increase in serum creatinine of >0.3 mg/dL (26.5 μmol/L) within 48 hours after contrast exposure.
    3. Urine output <0.5 mL/kg/h for at least 6 consecutive hours post-procedure.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2021
  2. Study start11 Feb 2021
  3. Primary completion1 Feb 2025
  4. Study completion1 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
1,586 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04918030
Sponsor's protocol ID
2020YLK14
Acronym
SAGED
Status last verified
Dec 2025
First submitted
24 May 2021
Last updated
12 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data sharing could be considered upon the proposal was approved

Publications

  • Chen X, Li S, Wang B, Chen G, Yao Y, He Y, Wu X, Yang Y, Kang H, Ding L, Cheng Y, Shen Q, Guo H, Wang J, Wen S, Zhu L, Xing Y, Tong Q, Li P, Liu Y, Peng X, Chen SL, Wang Y. Staged interventional strategies for acute ST-segment elevation myocardial infarction patient with multivessel disease: Rationale and design of a multicenter, randomized STAGED trial. Am Heart J. 2026 May;295:107352. doi: 10.1016/j.ahj.2026.107352. Epub 2026 Jan 13.

    PubMed 41539383

Questions about this trial

What is this clinical trial studying?

A study testing Early staged PCI and Late staged PCI in people with STEMI and Multi Vessel Coronary Artery Disease, run by Xiamen Cardiovascular Hospital, Xiamen University 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 12 Dec 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Major adverse cardiac event (MACE), defined as cardiovascular death, MI, ischemia-driven revasculrization (for both culprit and non-culprit lesions). (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04918030, which also lists 1 linked publication.

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 12 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in