Multi-cap for Increase Adherence After Acute Myocardial Infarction
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Adherence
研究概览
简要总结
Patients who survive an acute coronary syndrome are at high risk of recurrent events and death in the first months of evolution. Aspirin, angiotensin-converting enzyme, beta-blockers and statins decrease the risk of recurrent events and death, so are the recommended treatment for most patients who had a heart attack, and adherence to these recommendations is associated better clinical outcome. However, numerous studies show high dropout rate of medical treatment. The cause of nonadherence, common problem in chronic diseases, is multifactorial (economic, cultural, adverse effects), the complexity of the treatment being prescribed a relevant factor as a cause of non-compliance. The investigators goal is to assess whether the simplification of treatment for secondary prevention in a once-daily capsule containing four drugs increased adherence to it, compared to the standard treatment of each drug separately.
The investigators design a controlled, randomized, open, parallel-group clinical study. Patients will be randomized to one of the following treatment regimens:
- Combined-Capsule: capsule containing an adjusted patient combination scheme for secondary prevention of once daily.
- Usual-treatment: each component of the dish separately as is the usual practice.
The primary endpoint is the adherence of the treatment regimen to secondary prevention. For the study was considered adherent to a patient taking at least 80% of medication that belongs in the period.
详细描述
Sample Size Is estimated according to previous studies adherence to medical treatment 40%, and the objective of the study is to demonstrate an increase in adherence of 25% in absolute terms (40 to 65%) by simplifying the treatment regimen. With a parallel design, a type I error of 5%, a sample of 200 patients would give the study a power of 80% to detect this difference.
A study of this size would also give us increased 80% power to detect a difference of 14 mg / dl in serum cholesterol (estimated standard deviation 30 mg / dl) with an alpha error rate of 5%; and 80% power to detect a difference of 4 mmHg in systolic blood pressure (standard deviation 10 mmHg), also with a type I error of 5%
Procedures
After signing the written informed consent patients will be randomized in a 1:1 ratio, one of the study groups:
- Group 1: Conventional treatment: is a daily tablet of ramipril (5-10 mg / day), atenolol (50-100 mg / day), aspirin 100 mg / day and simvastatin 40 mg / day. The doses of drugs may be increased according to blood pressure and heart rate of patients in follow-up visits.
- Group 2: one capsule containing ramipril (5 to 10 mg), atenolol (50 to 100 mg), 100 mg aspirin, 40 mg simvastatin. In follow-up visits doses of atenolol and ramipril capsules may be adjusted according to blood pressure and heart rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Over 18 years old
- •Myocardial infarction within seven (7) days prior: anginal symptoms with ST-segment changes (elevation or depression) or inversion of T waves or left bundle branch block and acute elevation of cardiac enzymes.
- •Signature of written informed consent
排除标准
- •Severe ventricular dysfunction, (ejection fraction of the left ventricle less than 40%)
- •Contraindication for beta-blockers, angiotensin-converting enzyme, aspirin and / or statins.
- •History of allergies or adverse reactions to some of the study drug reactions. Chronic treatment with NSAIDs. Planned coronary-revascularization within six months after discharge.
- •Renal failure with estimated creatinine clearance according to the Cockroft-Gault formula less than 30 ml / min.
- •Liver or elevated transaminases before randomization more than three times the upper normal limit.
- •Higher fasting triglycerides 500 mg / dl.
- •Indication according to medical criteria other than a beta-blocker atenolol.
- •Indication of oral anticoagulation.
- •Failure to follow due to difficulties of geographical access.
研究组 & 干预措施
Combined capsule
Combined capsule containing ramipril (5 to 10 mg), atenolol (50 to 100 mg), 100 mg aspirin, 40 mg simvastatin. In follow-up visits doses of atenolol and ramipril capsules may be adjusted according to blood pressure and heart rate.
干预措施: Combined capsule (Other)
Conventional treatment
Usual therapy
干预措施: Conventional therapy (Other)
结局指标
主要结局
Adherence
时间窗: Six months
The adherence will be measures by pill count. It will presented as the percentage of pill taken on total theoretical pill that should be taken during the study period.
次要结局
- Blood pressure, heart rate and cholesterol levels(Six months)
研究者
Carlos Tajer
MD
Hospital El Cruce