A phase IV study to investigate the safety andeffectiveness of Rivaroxaban(Xarelto) 2.5mg(BID plusAcetylsalicylic Acid (ASA) 75 mg OD in Indian patientswith coronary and or symptomatic peripheral artery disease
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 18
- 主要终点
- Number of participants with haemorrhagic events and complications [ Time Frame: Up to 13 months ]
研究概览
简要总结
The proposed study is a post authorization safety study that
aims to collect the safety and effectiveness data on use of
rivaroxaban 2.5 mg [BID] with ASA 75mg [OD] for the
prevention of atherothrombotic events in adult patients in CAD
or symptomatic PAD at high risk of ischaemic events and is a
regulatory commitment to the Indian Health Authority. The
study also aims to collect real-world data on treatment patterns
and decision points for treatment with rivaroxaban 2.5
mg[BID] in patients with CAD or symptomatic PAD across the
broad range of patient risk profiles encountered in routine
clinical practice. A single arm design has been outlined as no
other regimen has been approved in this specific CAD or
symptomatic PAD population hence there is no suitable
comparator available. The local study protocol needs to be
submitted to the Indian Health Authority for approval.
The primary objective in this study is:
• To describe safety outcomes in CAD or PAD patients
treated with rivaroxaban 2.5 mg [BID] plus ASA 75 mg
[OD].
The secondary objectives in this study are:
ï‚· To describe effectiveness outcomes in CAD or PAD
patients treated with rivaroxaban 2.5 mg [BID] plus
ASA 75 mg [OD]
ï‚· To describe treatment patterns in CAD or symptomatic
PAD patients treated with rivaroxaban 2.5 mg [BID] plus ASA 75mg [OD]
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adult (≥18 years) female or male patient
- •Diagnosis of CAD or PAD
- •Decision to treat the patient with Rivaroxaban 2.5mg [BID] , co-administered with ASA 75mg[OD], for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events has been made by the investigator
- •Patient is willing to participate in the study (signed informed consent).
排除标准
- •Patients with haemoglobin level less than 10 gm/dl
- •Patients with clinically significant active bleeding (e.g., intracranial bleeding, gastrointestinal bleeding).
- •Patients with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk
- •In patients with severe renal impairment (Cr Cl<15 ml/min)
- •Patients with a history of GI bleeding
- •CAD or PAD patients with previous haemorrhagic or lacunar stroke
- •History of hypersensitivity or known contraindication for rivaroxaban, aspirin
- •Patients who will be treated with chronic anticoagulation therapy other than rivaroxaban 2.5 mg given for CAD/PAD.
- •Patient is a pregnant women and nursing mother Participation in an investigational program with interventions outside of routine clinical practice.
结局指标
主要结局
Number of participants with haemorrhagic events and complications [ Time Frame: Up to 13 months ]
时间窗: upto 13 months
Consisting of minor and major bleeding events. The major bleeding complications are collected according to the International Society on Thrombosis and Haemostasis (ISTH) criteria as a composite of fatal bleeding, symptomatic bleeding into a critical organ (such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome), bleeding into surgical site requiring reoperation, bleeding leading to hospitalization
时间窗: upto 13 months
次要结局
- MACE: composite of MI, stroke, and cardiovascular death (and single components)(MALE: major adverse limb events, incl. major amputation (and single components)and)