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1-month vs 12-month DAPT for ACS Patients Who Underwent PCI Stratified by IVUS: IVUS-ACS and ULTIMATE-DAPT Trials

Primary Purpose

Coronary Artery Disease

Status

Active

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

AntiPlatelet therapy

Percutaneous coronary intervention

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Enrollment into the study will require meeting at least one of these clinical syndromes within 1 month.

Unstable angina, defined as rest pain for 5-30 minutes or deteriorative exertional angina with either a) transient ST segment depression or elevation, or b) angiography showing a visually estimated diameter stenosis ≥90% or a ruptured plaque or thrombotic lesion
Non-ST elevation myocardial infarction (NSTEMI), defined as positive troponin consistent with clinical syndrome.
ST elevation MI (STEMI)

Exclusion Criteria:

Unable or unwilling to provide informed consent
Stroke within 3 months or any permanent neurologic deficit, and prior intracranial bleed, or any intracranial disease such as aneurysm or fistula
Previous coronary artery bypass graft (CABG)
Any planned surgery within 90 days
Any reason why any antiplatelet therapy might need to be discontinued within 12 months
Severe chronic kidney disease defined as an estimated glomerular filtration rate (eGFR) < 20 ml/min/1.73m^2
Need for chronic oral anticoagulation (warfarin/coumadin or direct oral anticoagulants)
Platelet count < 100,000 mm^3
Contraindication to aspirin
Contraindication to ticagrelor
Liver cirrhosis
Women of child-bearing potential
Life expectancy < 1 year
Any condition likely to interfere with study processes including medication compliance or follow-up visits (e.g. dementia, alcohol abuse, severe frailty, long distance to travel for follow-up visits, etc.)

Sites / Locations

Nanjing First Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

IVUS-guidance

Angiography-guidance

SAPT group

DAPT group

Arm Description

In the IVUS-guided DES implantation group, optimal stent deployment criteria included: 1) the MLA in the stented segment is >5.0 mm^2, or 90% of the MLA at the distal reference segments; 2) plaque burden 5-mm proximal or distal to the stent edge is <55%; and 3) absence of >=Type B edge dissection. Further treatment will be required if any of those 3 criteria was not met.

In the Angiography-guided DES implantation group, stent diameter and length will be selected by visual estimation with a stent/artery ratio of 1.1:1.0. Post-dilation with a noncompliant balloon (balloon/stent diameter=1.0:1.0) inflated at >18 atm will be performed for all lesions. Angiographic success is defined as Thrombolysis In Myocardial Infarction (TIMI) grade 3, residual stenosis <20%, and the absence of >Type B dissection.

Ticagrelor + aspirin for 1 month followed by ticagrelor plus matching placebo for an additional 11 months.

Ticagrelor + aspirin for 12 month.

Outcomes

Primary Outcome Measures

Target vessel failure (TVF)

The difference in TVF will be calculated from 0 month to 12 months between IVUS- and Angiography guidance groups.

Clinically-relevant bleeding

The difference in clinically-relevant bleeding (BARC ≥2) will be calculated from 1 month to 12 months between SAPT and DAPT groups.

Major adverse cardiovascular and cerebrovascular events (MACCE)

The difference in MACCE will be calculated from 1 month to 12 months between SAPT and DAPT groups.

Secondary Outcome Measures

Net adverse clinical events (NACE)

The difference in NACE between IVUS- and Angiography guidance groups, or SAPT and DAPT groups.

Full Information

NCT ID

NCT03971500

First Posted

May 30, 2019

Last Updated

November 18, 2022

Sponsor

Nanjing First Hospital, Nanjing Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03971500

Brief Title

1-month vs 12-month DAPT for ACS Patients Who Underwent PCI Stratified by IVUS: IVUS-ACS and ULTIMATE-DAPT Trials

Official Title

Comparison of 1-month Versus 12-month Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stents Guided by Either Intravascular Ultrasound or Angiography in Patients With Acute Coronary Syndrome: The Prospective, Multicenter, Randomized, Placebo-controlled IVUS-ACS and ULTIMATE-DAPT Trials

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

August 20, 2019 (Actual)

Primary Completion Date

October 27, 2023 (Anticipated)

Study Completion Date

September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nanjing First Hospital, Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Prospective, multicenter, randomized, double-blind, placebo-controlled trials.

Detailed Description

A total of 3486 subjects with ACS who met inclusion criteria and do not have any exclusion criterion will be randomized to IVUS- or Angiography-guidance group (first randomization). In the IVUS-guidance group, IVUS will be used to evaluate the lesion's specificity and to measure lesion length, landing zone, and reference vessel diameter prior-to stenting; and to assess stent expansion, extension, apposition, and possible complications after stent implantation. The IVUS- defined criteria for the optimal stent deployment included: 1) the minimal stent area (MSA) in the stented segment is >5.0 mm^2, or 90% of the MLA at the distal reference segments; 2) plaque burden 5-mm proximal or distal to the stent edge is <55%; and 3) absence of >Type B edge dissection. Further treatment will be required if stenting procedure is defined as suboptimal according to IVUS definition. IVUS will be not allowed to be used in the Angiography-guidance group. Those patients who have had no death, STEMI, stroke, ST, TVR or major bleeding (BARC 3 or 5) within 30 days and have continued on aspirin and ticagrelor for 30 days without interruption for >48 hours will be randomized 1:1 to: Ticagrelor plus+ matching placebo for an additional 11 months (SAPT group) Ticagrelor plus aspirin (study drug) for an additional 11 months (DAPT group) Follow-up of all subjects will continue for 1 year with an option for additional follow-up to 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Patients will undergo 1:1 randomization (first randomization) to either IVUS-guided DES implantation which will be the treatment group or Angio-guided DES implantation which will be the control group based on an online Clinical Research Data Management Platform. The initiation of the trial is defined as the time of randomization. After study subjects' enrollment and randomization, the study intervention will take place immediately. The follow-up visits for the primary TVF endpoint are scheduled at 1, 4, 6, and 12 months after the index procedure. Patients will undergo 1:1 randomization (second randomization) to either SAPT which will be the treatment group or DAPT which will be the control group based on an online Clinical Research Data Management Platform. The follow-up visits for the primary superiority bleeding endpoint and non-inferiority ischemic endpoint are scheduled at 3, 5, and 11 months after the second randomization.

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

3710 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IVUS-guidance

Arm Type

Experimental

Arm Description

Arm Title

Angiography-guidance

Arm Type

Active Comparator

Arm Description

Arm Title

SAPT group

Arm Type

Experimental

Arm Description

Ticagrelor + aspirin for 1 month followed by ticagrelor plus matching placebo for an additional 11 months.

Arm Title

DAPT group

Arm Type

Active Comparator

Arm Description

Ticagrelor + aspirin for 12 month.

Intervention Type

Drug

Intervention Name(s)

AntiPlatelet therapy

Other Intervention Name(s)

ticagrelor, aspirin

Intervention Description

AntiPlatelet therapy with ticagrelor + aspirin or ticagrelor alone.

Intervention Type

Procedure

Intervention Name(s)

Percutaneous coronary intervention

Other Intervention Name(s)

PCI

Intervention Description

PCI with DES implantation

Primary Outcome Measure Information:

Title

Target vessel failure (TVF)

Description

The difference in TVF will be calculated from 0 month to 12 months between IVUS- and Angiography guidance groups.

Time Frame

12 months

Title

Clinically-relevant bleeding

Description

The difference in clinically-relevant bleeding (BARC ≥2) will be calculated from 1 month to 12 months between SAPT and DAPT groups.

Time Frame

11 months

Title

Major adverse cardiovascular and cerebrovascular events (MACCE)

Description

The difference in MACCE will be calculated from 1 month to 12 months between SAPT and DAPT groups.

Time Frame

11 months

Secondary Outcome Measure Information:

Title

Net adverse clinical events (NACE)

Description

The difference in NACE between IVUS- and Angiography guidance groups, or SAPT and DAPT groups.

Time Frame

12 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Enrollment into the study will require meeting at least one of these clinical syndromes within 1 month. Unstable angina, defined as rest pain for 5-30 minutes or deteriorative exertional angina with either a) transient ST segment depression or elevation, or b) angiography showing a visually estimated diameter stenosis ≥90% or a ruptured plaque or thrombotic lesion Non-ST elevation myocardial infarction (NSTEMI), defined as positive troponin consistent with clinical syndrome. ST elevation MI (STEMI) Exclusion Criteria: Unable or unwilling to provide informed consent Stroke within 3 months or any permanent neurologic deficit, and prior intracranial bleed, or any intracranial disease such as aneurysm or fistula Previous coronary artery bypass graft (CABG) Any planned surgery within 90 days Any reason why any antiplatelet therapy might need to be discontinued within 12 months Severe chronic kidney disease defined as an estimated glomerular filtration rate (eGFR) < 20 ml/min/1.73m^2 Need for chronic oral anticoagulation (warfarin/coumadin or direct oral anticoagulants) Platelet count < 100,000 mm^3 Contraindication to aspirin Contraindication to ticagrelor Liver cirrhosis Women of child-bearing potential Life expectancy < 1 year Any condition likely to interfere with study processes including medication compliance or follow-up visits (e.g. dementia, alcohol abuse, severe frailty, long distance to travel for follow-up visits, etc.)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shao-Liang Chen, MD, PhD

Organizational Affiliation

Nanjing First Hospital, Nanjing Medical University

Official's Role

Study Chair

Facility Information:

Facility Name

Nanjing First Hospital

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210006

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30261237

Citation

Zhang J, Gao X, Kan J, Ge Z, Han L, Lu S, Tian N, Lin S, Lu Q, Wu X, Li Q, Liu Z, Chen Y, Qian X, Wang J, Chai D, Chen C, Li X, Gogas BD, Pan T, Shan S, Ye F, Chen SL. Intravascular Ultrasound Versus Angiography-Guided Drug-Eluting Stent Implantation: The ULTIMATE Trial. J Am Coll Cardiol. 2018 Dec 18;72(24):3126-3137. doi: 10.1016/j.jacc.2018.09.013. Epub 2018 Sep 24.

Results Reference

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PubMed Identifier

33621541

Citation

Ge Z, Gao XF, Kan J, Kong XQ, Zuo GF, Ye F, Tian NL, Lin S, Liu ZZ, Shao YB, He YQ, Wen SY, Yang Q, Xia Y, Wang ZZ, Xiao PX, Li F, Zeng HS, Yang S, Wang Y, Tao L, Gao DS, Qu H, Qian XS, Han YL, Chen F, Zhang JJ, Chen SL. Comparison of one-month versus twelve-month dual antiplatelet therapy after implantation of drug-eluting stents guided by either intravascular ultrasound or angiography in patients with acute coronary syndrome: rationale and design of prospective, multicenter, randomized, controlled IVUS-ACS and ULTIMATE-DAPT trial. Am Heart J. 2021 Jun;236:49-58. doi: 10.1016/j.ahj.2021.02.014. Epub 2021 Feb 20.

Results Reference

background

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1-month vs 12-month DAPT for ACS Patients Who Underwent PCI Stratified by IVUS: IVUS-ACS and ULTIMATE-DAPT Trials

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