NCT03889574已完成不适用
Triple Antithrombotic Therapy in Cardiac Patients Requiring Revascularization
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Comparison between warfarin based triple therapy versus NOAC-based triple therapy in cardiac patients
研究概览
简要总结
Aim(s)/Objective(s)
- To evaluate the safety and efficacy of triple antithrombotic therapy in patients taking DAPT of aspirin and a P2Y12 inhibitor in addition to either a NOAC or warfarin for the prevention of thromboembolic or acute coronary syndrome (ACS) events in patients with non-valvular atrial fibrillation (AF), history of coronary artery disease (CAD)/stent placement or recurrent ACS event.
- To determine the Methodist Health System (MHS) prescribing practices and patterns in cardiac patients with a history of AF who are admitted for CAD or an ACS event requiring PCI.
Hypothesis Primary Hypothesis Cardiac patients with a history of AF and an indication for long-term NOAC who are also prescribed DAPT following an ASC event or revascularization with stenting will demonstrate a significant difference in cardiovascular outcomes and major bleeding events when compared with warfarin-based triple therapy.
详细描述
STUDY DESIGN
- Multi-center, retrospective cohort chart review study design
- Data will be collected on all triple therapy recipients who were discharged from a Methodist Health System (MHS) facility with prescriptions for a combination of aspirin, P2Y12 Inhibitor and an OAC of either a NOAC or warfarin between April 1, 2017 - April 1, 2018
- Patient list will be generated in EPIC
- All data will be obtained from EPIC
- All data will be collected retrospectively after the patient is discharged from the hospital
- Data collection (planned completion date): May 2019
Study Inclusion Criteria:
- 18 years or older
- AF diagnosis
- ICD10 for ACS, STEMI or NSTEMI
- Discharged with triple therapy agents of aspirin, P2Y12 inhibitor (clopidogrel, prasugrel, or ticagrelor), and OAC (warfarin, edoxaban, dabigatran, rivaroxaban, or apixaban) status post-stent
Study Exclusion Criteria:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• 18 years or older
- •AF diagnosis
- •ICD10 for ACS, STEMI or NSTEMI
- •Discharged with triple therapy agents of aspirin, P2Y12 inhibitor (clopidogrel, prasugrel, or ticagrelor), and OAC (warfarin, edoxaban, dabigatran, rivaroxaban, or apixaban) status post-stent
排除标准
- •• Patients less than 18 years of age
- •Prior intracranial bleeding prior to study start date
- •GI hemorrhage within 1 month prior to study start date
- •Major bleeding event with 1 month prior to study start date
- •Hemorrhage disorder
- •Stroke within 1 month prior to study start date
- •Cardiogenic shock during admission at start date
- •Contraindication to use of the study medications
- •Peptic ulcer in the prior 6 months prior to study start date
- •Thrombocytopenia (platelet concentration lower than 50×109/L)
- •Thrombolysis In Myocardial Infarction (TIMI) major bleeding in the prior 12 months of study start date
- •Pregnancy
- •History of DVT or PE currently on OAC
结局指标
主要结局
Comparison between warfarin based triple therapy versus NOAC-based triple therapy in cardiac patients
时间窗: April 1, 2017 - April 1, 2018
To compare the incidence of MACE, stroke (ischemic and hemorrhage), MI (STEMI and NSTEMI), stent thrombosis, systemic embolism (VTE), death (all-cause, cardiac and non-cardiac) and CAD-associated hospitalizations/ED visits) in patients who received warfarin-based triple therapy versus NOAC-based triple therapy.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Triple or Dual Antithrombotic Therapy After PCI (TRIDUAL-PCI) Coronary Intervention in Patients With Non-valvular Atrial Fibrillation. Real-world Italian Multicenter Registry (TRIDUAL-PCI)Anticoagulant-induced BleedingCoronary DiseaseAtrial FibrillationMyocardial InfarctionNCT04291287Scientific Institute San Raffaele1,500
招募中
不适用
Efficacy and Safety of Triple-targeted Drug Therapy in Treatment-naive Patients With Non-low-risk PAH: A Real-world, Multicenter StudyArterial Pulmonary Hypertension (PAH)NCT06753981Qianfoshan Hospital48
已完成
不适用
EYESHOT (EmploYEd Antithrombotic Therapies in Patients With Acute Coronary Syndromes HOspitalized in iTalian Coronary Care Units)Acute Coronary SyndromesNCT02015624Heart Care Foundation2,597
招募中
4 期
NOAC Therapy Guided by PARIS Risk Score and D-dimer in Patients With ACS After PCIPercutaneous Coronary InterventionCoronary Artery DiseaseAcute Coronary SyndromeNCT05638867China National Center for Cardiovascular Diseases3,944
Unknown
不适用
Bleeding Events After Triple Antithrombotic Therapy Initiation.BleedingNCT03203980Central Hospital, Nancy, France200