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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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ClinicalTrials.gov Identifier: NCT03971500
Recruitment Status : Recruiting
First Posted : June 3, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Shaoliang Chen, Nanjing First Hospital, Nanjing Medical University

Brief Summary:
Prospective, multicenter, randomized, double-blind, placebo-controlled trials.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: AntiPlatelet therapy Procedure: Percutaneous coronary intervention Not Applicable

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 MACCE 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:

  1. Ticagrelor plus+ matching placebo for an additional 11 months (SAPT group)
  2. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3486 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 20, 2019
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IVUS-guidance
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.
Drug: AntiPlatelet therapy
AntiPlatelet therapy with ticagrelor + aspirin or ticagrelor alone.
Other Name: ticagrelor, aspirin

Procedure: Percutaneous coronary intervention
PCI with DES implantation
Other Name: PCI

Active Comparator: Angiography-guidance
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.
Drug: AntiPlatelet therapy
AntiPlatelet therapy with ticagrelor + aspirin or ticagrelor alone.
Other Name: ticagrelor, aspirin

Procedure: Percutaneous coronary intervention
PCI with DES implantation
Other Name: PCI

Experimental: SAPT group
Ticagrelor + aspirin for 1 month followed by ticagrelor plus matching placebo for an additional 11 months.
Drug: AntiPlatelet therapy
AntiPlatelet therapy with ticagrelor + aspirin or ticagrelor alone.
Other Name: ticagrelor, aspirin

Procedure: Percutaneous coronary intervention
PCI with DES implantation
Other Name: PCI

Active Comparator: DAPT group
Ticagrelor + aspirin for 12 month.
Drug: AntiPlatelet therapy
AntiPlatelet therapy with ticagrelor + aspirin or ticagrelor alone.
Other Name: ticagrelor, aspirin

Procedure: Percutaneous coronary intervention
PCI with DES implantation
Other Name: PCI




Primary Outcome Measures :
  1. Target vessel failure (TVF) [ Time Frame: 12 months ]
    The difference in TVF will be calculated from 0 month to 12 months between IVUS- and Angiography guidance groups.

  2. Clinically-relevant bleeding [ Time Frame: 11 months ]
    The difference in clinically-relevant bleeding (BARC ≥2) will be calculated from 1 month to 12 months between SAPT and DAPT groups.

  3. Major adverse cardiovascular and cerebrovascular events (MACCE) [ Time Frame: 11 months ]
    The difference in MACCE will be calculated from 1 month to 12 months between SAPT and DAPT groups.


Secondary Outcome Measures :
  1. Net adverse clinical events (NACE) [ Time Frame: 12 months ]
    The difference in NACE between IVUS- and Angiography guidance groups, or SAPT and DAPT groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03971500


Contacts
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Contact: Shao-Liang Chen, MD, PhD +86-25-52208048 chmengx@126.com
Contact: Jing Kan, MPH +86-25-52271398 kanjingok@126.com

Locations
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China, Jiangsu
Nanjing First Hospital Recruiting
Nanjing, Jiangsu, China, 210006
Contact: Shaoliang Chen, MD    +86 13605157029    chmengx@126.com   
Contact: Jing Kan, MPH    +86 15305140515    kanjingok@126.com   
Sponsors and Collaborators
Nanjing First Hospital, Nanjing Medical University
Investigators
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Study Chair: Shao-Liang Chen, MD, PhD Nanjing First Hospital, Nanjing Medical University

Publications of Results:
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Responsible Party: Shaoliang Chen, Vice President, Nanjing First Hospital, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03971500     History of Changes
Other Study ID Numbers: NFH20190529
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Ticagrelor
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents