Effect of Primidone on Platelet Responsiveness in Patients Determined to be Clopidogrel Resistant
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Platelet Aggregometry
研究概览
简要总结
The purpose of this study is to determine whether adding primidone will improve the metabolism of clopidogrel thereby increasing metabolite levels within the blood stream and platelet response to clopidogrel in patients who were previously found to lack adequate response to clopidogrel. This information could help overcome clopidogrel resistance in patients who are at risk for stroke or transient ischemic attack (TIA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Males and females aged 18 - 90 years who are clopidogrel resistant as determined by whole blood aggregometry
- •Patients with a low risk of new cerebrovascular ischemic events as indicated by an Essen Stroke Risk Score of less than three
排除标准
- •Any history of allergy or intolerance to either Plavix or clopidogrel
- •Any history of allergy or intolerance to either Mysoline or primidone
- •Any clinically significant abnormalities in complete blood count as determined by the investigator
- •Use of any acute medications within the last two weeks or initiation of any non-study medications during the study period that would effect CYP enzymes or platelet function
- •Use of tobacco products from 2 weeks prior to enrollment in the study and throughout the duration of the study
- •Any planned surgical procedures during the study or 5 days after the study has ended
- •History of alcoholism or alcohol abuse
- •Participants who have had any alcohol consumption within 24 hours of a blood draw
- •Previous stroke in past 3 months
- •Participants who are or are planning to become pregnant
- •Participants who of reproductive potential must agree to use a method of contraception for the duration of the study as well as 4 weeks after participation is complete
- •Change in any medications that could affect liver enzymes or platelet aggregation throughout the study
- •Compliance less than 80 % based on pill counts on two different study visits
研究组 & 干预措施
Primidone
Participants will receive primidone in addition to their clopidogrel regimen. For the first 3 days of the study, participants will take 125 mg of primidone (one-half tablet). After 3 days of 125 mg, the primidone dose will be increased to 250 mg (1 tablet) taken at bedtime for the next 17-25 days. The participant will then be asked to return and be retested.
干预措施: Primidone (Drug)
结局指标
主要结局
Platelet Aggregometry
时间窗: Platelet aggregometry will be performed at Visit 1 and Visit 2 which will be 20-28 days following Visit 1.
Platelet Aggregometry will be used to assess platelet responsiveness to clopidogrel following treatment with investigational medication. Blood will be placed in plastic cuvettes and probes will be inserted. Wires on the probes measure platelet aggregation in electrical impedance. A baseline is obtained and then adenosine diphosphate (ADP) is added to cause aggregation. Clopidogrel prevents platelet aggregation through irreversible binding of its active metabolite to the ADP receptors on the platelet surface. The change in impedance from baseline is directly proportional to the extent of platelet aggregation and is expressed in ohms of resistance.
次要结局
- Area Under the Curve of Clopidogrel Metabolite Levels(Metabolite Levels Drawn 30 minutes, 1 hour, 2 hours, 3 hours and 4 hours post clopidogrel dose at Visit 1 and Visit 2 which will be 20-28 days following Visit 1.)