A Randomized, Double-blind, Placebo-controlled Crossover Trial of Antiplatelet Therapies in Psoriasis
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean change in the composite endothelial pro-inflammatory transcript expression
研究概览
简要总结
The purpose of this study is to determine the effect of antiplatelet therapy on the endovascular phenotype in psoriasis, specifically whether clopidogrel reduces vascular endothelial pro-atherosclerotic transcript expression more than aspirin or placebo. The primary endpoint is mean change in a composite endothelial pro-inflammatory/pro-atherosclerotic transcript expression signature measured from brachial vein endothelial cells.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •One of the following:
- •A history of psoriasis as confirmed by a board-certified dermatologist OR
- •A history of psoriatic arthritis as confirmed by a board-certified rheumatologist
- •Age ≥ 18 & < 90 years
- •Able and willing to provide written informed consent for the study
- •English-speaking unless a translated informed consent form is approved
- •No previous antiplatelet or anticoagulant use for 14 days prior to enrollment
排除标准
- •A prior history of a myocardial infarction, stroke/TIA, or occlusive peripheral arterial disease
- •Chronic antiplatelet/anticoagulant use that is not able to be stopped at least 14 days prior to study enrollment
- •Uncontrolled hypertension resting systolic blood pressure > 180 mm Hg or diabetes HbA1c > 10%
- •Known active cancer receiving treatment
- •Anemia (hemoglobin < 9 mg/dl) or thrombocytopenia (Platelet count <75), or thrombocytosis (Platelet count >600)
- •A history of severe bleeding or bleeding disorders
- •Active gastrointestinal ulcer
- •Active pathological bleeding.
- •Chronic kidney disease (CrCl < 30ml/min)
- •Congestive heart failure
- •Known hypersensitivity to or allergy to aspirin, clopidogrel, or any of the components of the study capsules
- •History of aspirin-exacerbated respiratory disease or asthma induced by salicylates or NSAIDs
- •Currently breastfeeding
- •Persons of childbearing potential unwilling to use acceptable contraception during the study
研究组 & 干预措施
Aspirin, then Clopidogrel, then Placebo
Each subject will take an aspirin 81mg capsule daily for 4 weeks. After a washout period of 4 weeks, they will take the clopidogrel 75mg capsule daily for 4 weeks. After a second washout period of 4 weeks, they will take the Placebo capsule daily for 4 weeks.
干预措施: Placebo (Other)
Aspirin, then Placebo, then Clopidogrel
Each subject will take an aspirin 81mg capsule daily for 4 weeks. After a washout period of 4 weeks, they will take the Placebo capsule daily for 4 weeks. After a second washout period of 4 weeks, they will take the clopidogrel 75mg capsule daily for 4 weeks.
干预措施: Placebo (Other)
Clopidogrel, then Aspirin, then Placebo
Each subject will take will take the clopidogrel 75mg capsule daily for 4 weeks. After a washout period of 4 weeks, they will take an aspirin 81mg capsule daily for 4 weeks. After a second washout period of 4 weeks, they will take the Placebo capsule daily for 4 weeks.
干预措施: Clopidogrel (Drug)
Clopidogrel, then Aspirin, then Placebo
Each subject will take will take the clopidogrel 75mg capsule daily for 4 weeks. After a washout period of 4 weeks, they will take an aspirin 81mg capsule daily for 4 weeks. After a second washout period of 4 weeks, they will take the Placebo capsule daily for 4 weeks.
干预措施: Placebo (Other)
Clopidogrel, then Placebo, then Aspirin
Each subject will take will take the clopidogrel 75mg capsule daily for 4 weeks. After a washout period of 4 weeks, they will take the Placebo capsule daily for 4 weeks. After a second washout period of 4 weeks, they will take an aspirin 81mg capsule daily for 4 weeks.
干预措施: Placebo (Other)
Placebo, then Aspirin, then Clopidogrel
Each subject will take will take the Placebo capsule daily for 4 weeks. After a washout period of 4 weeks, they will take an aspirin 81mg capsule daily for 4 weeks. After a second washout period of 4 weeks, they will take the clopidogrel 75mg capsule daily for 4 weeks.
干预措施: Placebo (Other)
Placebo, then Clopidogrel, then Aspirin
Each subject will take will take the Placebo capsule daily for 4 weeks. After a washout period of 4 weeks, they will take the clopidogrel 75mg capsule daily for 4 weeks. After a second washout period of 4 weeks, they will take an aspirin 81mg capsule daily for 4 weeks.
干预措施: Placebo (Other)
Placebo, then Aspirin, then Clopidogrel
Each subject will take will take the Placebo capsule daily for 4 weeks. After a washout period of 4 weeks, they will take an aspirin 81mg capsule daily for 4 weeks. After a second washout period of 4 weeks, they will take the clopidogrel 75mg capsule daily for 4 weeks.
干预措施: Clopidogrel (Drug)
Placebo, then Clopidogrel, then Aspirin
Each subject will take will take the Placebo capsule daily for 4 weeks. After a washout period of 4 weeks, they will take the clopidogrel 75mg capsule daily for 4 weeks. After a second washout period of 4 weeks, they will take an aspirin 81mg capsule daily for 4 weeks.
干预措施: Aspirin (Drug)
Placebo, then Clopidogrel, then Aspirin
Each subject will take will take the Placebo capsule daily for 4 weeks. After a washout period of 4 weeks, they will take the clopidogrel 75mg capsule daily for 4 weeks. After a second washout period of 4 weeks, they will take an aspirin 81mg capsule daily for 4 weeks.
干预措施: Clopidogrel (Drug)
Aspirin, then Clopidogrel, then Placebo
Each subject will take an aspirin 81mg capsule daily for 4 weeks. After a washout period of 4 weeks, they will take the clopidogrel 75mg capsule daily for 4 weeks. After a second washout period of 4 weeks, they will take the Placebo capsule daily for 4 weeks.
干预措施: Clopidogrel (Drug)
Aspirin, then Clopidogrel, then Placebo
Each subject will take an aspirin 81mg capsule daily for 4 weeks. After a washout period of 4 weeks, they will take the clopidogrel 75mg capsule daily for 4 weeks. After a second washout period of 4 weeks, they will take the Placebo capsule daily for 4 weeks.
干预措施: Aspirin (Drug)
Aspirin, then Placebo, then Clopidogrel
Each subject will take an aspirin 81mg capsule daily for 4 weeks. After a washout period of 4 weeks, they will take the Placebo capsule daily for 4 weeks. After a second washout period of 4 weeks, they will take the clopidogrel 75mg capsule daily for 4 weeks.
干预措施: Aspirin (Drug)
Aspirin, then Placebo, then Clopidogrel
Each subject will take an aspirin 81mg capsule daily for 4 weeks. After a washout period of 4 weeks, they will take the Placebo capsule daily for 4 weeks. After a second washout period of 4 weeks, they will take the clopidogrel 75mg capsule daily for 4 weeks.
干预措施: Clopidogrel (Drug)
Clopidogrel, then Placebo, then Aspirin
Each subject will take will take the clopidogrel 75mg capsule daily for 4 weeks. After a washout period of 4 weeks, they will take the Placebo capsule daily for 4 weeks. After a second washout period of 4 weeks, they will take an aspirin 81mg capsule daily for 4 weeks.
干预措施: Clopidogrel (Drug)
Placebo, then Aspirin, then Clopidogrel
Each subject will take will take the Placebo capsule daily for 4 weeks. After a washout period of 4 weeks, they will take an aspirin 81mg capsule daily for 4 weeks. After a second washout period of 4 weeks, they will take the clopidogrel 75mg capsule daily for 4 weeks.
干预措施: Aspirin (Drug)
Clopidogrel, then Aspirin, then Placebo
Each subject will take will take the clopidogrel 75mg capsule daily for 4 weeks. After a washout period of 4 weeks, they will take an aspirin 81mg capsule daily for 4 weeks. After a second washout period of 4 weeks, they will take the Placebo capsule daily for 4 weeks.
干预措施: Aspirin (Drug)
Clopidogrel, then Placebo, then Aspirin
Each subject will take will take the clopidogrel 75mg capsule daily for 4 weeks. After a washout period of 4 weeks, they will take the Placebo capsule daily for 4 weeks. After a second washout period of 4 weeks, they will take an aspirin 81mg capsule daily for 4 weeks.
干预措施: Aspirin (Drug)
结局指标
主要结局
Mean change in the composite endothelial pro-inflammatory transcript expression
时间窗: Baseline, Follow-up Visit 1 (Week 4)
This endpoint is a validated composite of 9 endothelial-derived pro-atherosclerotic transcripts which I have shown is elevated in psoriasis (CXCL1, IL-8, LTB, IL-1B, CCL3, ICAM1, COX-2, CCL2, CX3CL1), correlated with plaque burden and modifiable. The transcripts are expressed as the log-transformed normalized count values and assessed as (follow-up 4 weeks/baseline time 0).
Mean change in the composite endothelial pro-inflammatory transcript expression
时间窗: Baseline, Follow-up Visit 3 (Week 12)
This endpoint is a validated composite of 9 endothelial-derived pro-atherosclerotic transcripts which I have shown is elevated in psoriasis (CXCL1, IL-8, LTB, IL-1B, CCL3, ICAM1, COX-2, CCL2, CX3CL1), correlated with plaque burden and modifiable. The transcripts are expressed as the log-transformed normalized count values and assessed as (follow-up 4 weeks/baseline time 0).
Mean change in the composite endothelial pro-inflammatory transcript expression
时间窗: Baseline, Final Visit (Week 20)
This endpoint is a validated composite of 9 endothelial-derived pro-atherosclerotic transcripts which I have shown is elevated in psoriasis (CXCL1, IL-8, LTB, IL-1B, CCL3, ICAM1, COX-2, CCL2, CX3CL1), correlated with plaque burden and modifiable. The transcripts are expressed as the log-transformed normalized count values and assessed as (follow-up 4 weeks/baseline time 0).
次要结局
- Change in percent platelet aggregation(Baseline, Follow-up Visit 1 (Week 4))
- Change in percent platelet aggregation(Baseline, Follow-up Visit 3 (Week 12))
- Change in percent platelet aggregation(Baseline, Final Visit (Week 20))
- Change in platelet activation biomarkers(Baseline, Follow-up Visit 1 (Week 4))
- Change in platelet activation biomarkers(Baseline, Follow-up Visit 3 (Week 12))
- Change in platelet activation biomarkers(Baseline, Final Visit (Week 20))