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Ticagrelor With Low-dose Versus Regular Aspirin in Patients With Acute Coronary Syndrome (ACS) at High-Risk for Ischemia After Percutaneous Coronary Intervention (LD-ASPIRIN)

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ClinicalTrials.gov Identifier: NCT04240834
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Qian Haiyan, Fu Wai Hospital, Beijing, China

Brief Summary:
The present study is aimed to compare the safety and efficacy of Ticagrelor with low-dose Aspirin versus standard dual anti-platelet therapy (DAPT) in patients with acute coronary syndrome (ACS) at high risk for ischemic events after percutaneous coronary intervention (PCI) and stent implantation.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Interventional Cardiology Drug: Aspirin Drug: Ticagrelor Phase 3

Detailed Description:
This is a prospective, randomized, open-label, blinded-endpoint evaluation, single-center Study. There will be 1220 ACS patients at high risk for ischemic events after successful PCI with implantation of at least one drug eluting stent who will be enrolled in Fuwai Hospital, China. Then those included subjects will be randomized to either Ticagrelor plus low-dose Aspirin (50mg daily, LD group) or Ticagrelor plus regular dose Aspirin (75mg daily, control group) for 12 months. The primary endpoint of the current study is to determine the impact of low-dose Aspirin plus Ticagrelor versus standard DAPT for 12 months on major adverse cardiac and cerebral events (MACCEs), and the secondary endpoint is to determine whether the protocol of low dose Aspirin plus Ticagrelor reduces bleeding events, sufficiently inhibits platelet function, and increases the medication adherence among the included patients. In summary, the present study is to provide new evidence and strategy about the anti-platelet protocol for ACS patients at high risk for ischemia.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Ticagrelor With Low-dose Aspirin Versus Regular Aspirin in Patients With Acute Coronary Syndrome at High-risk for Ischemia After Percutaneous Coronary Intervention: A Prospective, Randomized, Open-label, Blinded-endpoint Evaluation,Single-center, Phase 3 Study
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LD group
Low-dose Aspirin(50mg qd) + Ticagrelor( 90mg bid) for 12 months
Drug: Aspirin
Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT)
Other Name: Acetylsalicylic Acid

Drug: Ticagrelor
Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT)
Other Name: Brilinta/Brilique

Active Comparator: Control group
Regular Aspirin(75mg qd) + Ticagrelor(90mg bid) for 12 months
Drug: Aspirin
Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT)
Other Name: Acetylsalicylic Acid

Drug: Ticagrelor
Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT)
Other Name: Brilinta/Brilique




Primary Outcome Measures :
  1. Major adverse cardiac and cerebral events (MACCEs) [ Time Frame: 12 months after randomization ]
    Number of participants with a composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke or urgent target vessel revascularization


Secondary Outcome Measures :
  1. Bleeding episode (Key secondary endpoint) [ Time Frame: 12 months after randomization ]
    Number of participants with major bleeding(Bleeding Academic Research Consortium (BARC) types ≥3) and/or minor bleeding(Bleeding Academic Research Consortium (BARC) types 0-2)

  2. Platelet function [ Time Frame: 12 months after randomization ]
    Platelet inhibition, blood level and urine level of thromboxaneB2(TXB2)

  3. Medication adherence [ Time Frame: 12 months after randomization ]
  4. Bleeding-related withdrawal [ Time Frame: 12 months after randomization ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ACS patients at high risk for ischemic events after successful PCI with implantation of at least one drug eluting stent
  • Able and willing to provide informed consent and participate in 12 months follow-up period
  • Able to receive DAPT treatment
  • Enrollment into the study will require meeting at least one angiographic inclusion and none of the exclusion criteria.

Angiographic Inclusion Criteria:

  1. LM lesion requiring stents
  2. Proximal LAD lesion(s) requiring stents
  3. Bypass grafts lesion(s) requiring stents
  4. Overall stent length ≥60 mm
  5. History of in-stent thrombosis
  6. Bifurcation lesions requiring at least 2 stents
  7. Over two vessels lesions requiring stents
  8. Calcified target lesion(s) requiring atherectomy
  9. The intraoperative occurrence of no-reflow or slow-flow
  10. Compressed branch vessels with a diameter of at least 2.0 mm failing to reach flow restoration (at least TIMI 3)

Exclusion Criteria:

  • Need for chronic oral anticoagulation
  • With cardiomyopathy(HCM/DCM/RCM)
  • With severe ventricular arrhythmia requiring ICD implantation
  • With chronic respiratory disease (COPD, asthma, chronic bronchitis, pulmonary heart disease)
  • With severe infectious disease(active hepatitis B, active hepatitis C, AIDS)
  • With hematological disorders(thrombocytopenia, severe anemia, leukaemia)
  • With severe liver disease or kidney failure
  • With malignant tumor
  • With cognitive impairment
  • Unable or unwilling to provide informed consent or undergo follow-up

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): NCT04240834


Contacts
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Contact: Haiyan Qian, MD, PhD +8613811386143 ahqhy712@163.com
Contact: Zhiyao Wei +8615521192379 weizhiyaoyx@163.com

Locations
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China, Beijing
Fuwai Hospital
Beijing, Beijing, China
Contact: Haiyan Qian, MD, PhD    +8613811386143    ahqhy712@163.com   
Sponsors and Collaborators
Fu Wai Hospital, Beijing, China
Investigators
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Principal Investigator: Haiyan Qian, MD, PhD Fuwai Hospital, Beijing, China
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Responsible Party: Qian Haiyan, MD, PhD, Fu Wai Hospital, Beijing, China
ClinicalTrials.gov Identifier: NCT04240834    
Other Study ID Numbers: 2019XK320061
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Qian Haiyan, Fu Wai Hospital, Beijing, China:
ACS
PCI
DAPI
Aspirin
Ticagrelor
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Ischemia
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular 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