Differential EFfects of Dual antIplatelet and Dual aNtithrombotic thErapy on Hemostasis in Chronic Coronary Syndrome Patients: Define CCS Study, a Prospective Randomized Crossover Clinical Trial.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Bleeding time
研究概览
简要总结
The investigators will be comparing the effects of two different drug treatment strategies, in patients with history of a heart attack, on different markers of bleeding and clotting risk. Both treatment strategies are already approved for the indication of improving outcomes in high-risk patients with history of heart attack.
详细描述
The investigators will enroll patients with coronary disease >1 year after an acute coronary syndrome. Subjects will be randomized to one of two treatment plans. One plan the participant will take ticagrelor for one week, then take two weeks off with no drug (washout period), then one week of rivaroxaban. The other plan will be reverse order where the participant will take rivaroxaban for one week, then two weeks off(washout period), then one week of ticagrelor. Study drugs will be provided to participants at the start of each treatment period. Bleeding time will be determined and blood samples will be taken at four timepoints (baseline, post first drug, pre second drug, and post second drug) to measure complete blood count, CRP, and fibrin clot assessment. These are surrogate markers for safety (bleeding) and efficacy (increased thrombotic risk)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
Study personnel performing bleeding time and laboratory staff will be blinded to treatment allocation.
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic coronary syndrome (at least 1 year after having a myocardial infarction) on aspirin monotherapy will be eligible for this study. They have to have at least one of these additional risk factors:
- •Diffuse coronary artery disease.
- •Peripheral vascular disease
- •Chronic kidney disease (eGFR<60 ml/unit/1.73 m2)
排除标准
- •Allergy to either rivaroxaban or ticagrelor
- •Requirement for anticoagulation or P2Y12 inhibitor therapy
- •Anemia (hemoglobin < 10 g/dL)
- •Severe renal impairment (eGFR < 30 ml/unit/1.73 m2)
- •Bleeding disorders
- •Significant liver impairment resulting in deranged clotting parameters
- •Any history of intracranial hemorrhage
- •Stroke within 6 months
- •History of gastrointestinal bleed within 6 months
- •Major surgery within 1 month
- •Patients with inflammatory conditions
- •Concomitant treatment with immunosuppressive therapy, inhibitors or inducers of P glycoprotein or CYP3A4 enzymes (eg. azole antifungals, ritonavir, erythromycin, clarithromycin, rifampicin)
- •Concomitant treatment with antidepressants (selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors)
- •Pregnancy
- •Inability to give written consent
研究组 & 干预措施
Rivaroxaban first
Patients will be treated with rivaroxaban 2.5 mg twice a day for one week then on Day 21, will be treated with ticagrelor 60 mg twice a day for one week.
干预措施: Rivaroxaban (Drug)
Rivaroxaban first
Patients will be treated with rivaroxaban 2.5 mg twice a day for one week then on Day 21, will be treated with ticagrelor 60 mg twice a day for one week.
干预措施: Ticagrelor (Drug)
Ticagrelor first
Patients will be treated with ticagrelor 60 mg twice a day for one week then on Day 21, will be treated with rivaroxaban 2.5 mg twice a day for one week.
干预措施: Rivaroxaban (Drug)
Ticagrelor first
Patients will be treated with ticagrelor 60 mg twice a day for one week then on Day 21, will be treated with rivaroxaban 2.5 mg twice a day for one week.
干预措施: Ticagrelor (Drug)
结局指标
主要结局
Bleeding time
时间窗: 7 days
The primary objective is to determine the differential effect of rivaroxaban and ticagrelor on bleeding time as a surrogate marker for bleeding tendency.
次要结局
- Differential effects on inflammatory markers (white cell count and CRP)(7 days)
- Differential effects on fibrin clot lysis time(7 days)
研究者
Wael Sumaya
Interventional Cardiologist
Nova Scotia Health Authority