Ignite Creation Date:
2024-05-06 @ 3:23 AM
Last Modification Date:
2024-10-26 @ 11:32 AM
Study NCT ID:
NCT02271178
Status:
TERMINATED
Last Update Posted:
2017-01-11
First Post:
2014-10-03
Brief Title:
Multi-cap for Increase Adherence After Acute Myocardial Infarction
Sponsor:
Hospital El Cruce
Organization:
Hospital El Cruce
Study Overview
Official Title:
Multi-cap for Increase Adherence After Acute Myocardial Infarction
Status:
TERMINATED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was stopped after interim analysis due to futility
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 11 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
All other medications that the patient receives will be determined and adjusted doses as determined by the treating physician
In patients receiving 100 mg day and atenolol 10 mg day of ramipril and require additional treatment to control blood pressure will recommend using thiazide diuretics calcium channel blockers and alpha-methyldopa in that order
All other medications that the patient receives will be determined and adjusted doses as determined by the treating physician
In patients receiving 100 mg day and atenolol 10 mg day of ramipril and require additional treatment to control blood pressure will recommend using thiazide diuretics calcium channel blockers and alpha-methyldopa in that order
The first supply of study medication will be held on discharge from hospital Patients will be referred for follow-up at 7 days with an additional 7 days a month 3 months and six months final visit For visits 2 3 and 4 be tolerated fifteen 15 days before considering that the patient did not attend the visit
Randomization After signing the informed consent patients will be randomized in a 11 ratio to receive study treatments
Randomization was carried out with lists of random numbers generated by computer with a block diagram of 4 and 6 Was also a scheme will use stratified by gender and diabetes
The mapping is done using consecutive sealed opaque envelopes To minimize the risk of predicting the next treatment the envelopes will be handled by the pharmacy staff
After signing the informed consent was informed pharmacy staff concerned in the study who will open the appropriate envelope and will be responsible for the preparation and supply of medication Appendix 1
Data Anthropometric data risk factors cardiovascular history blood pressure measurements and basal heart rate were collected All patients will have lab tests including blood count with platelet count fasting blood glucose creatinine urea electrolytes liver function tests total cholesterol cholesterol bound to high density lipoprotein HDL and low density LDL and triglycerides
Blood pressure and pulse It is measured on the left arm with the subject seated after 5 minutes of rest Three blood pressure measurements separated by a minute averaged realized and the last two discarding the first value Diastolic blood pressure will be recorded in the fifth Korotkoff sound Heart rate will be measured by averaging two measurements of 30 seconds rhythm in patients with atrial fibrillation two periods of 1 minute averaged These measurements were repeated at each follow-up visit
Electrocardiogram ECG were performed at baseline and follow-up with the subject in supine position after 5 minutes of rest All are made with automatic ECG 12-lead equipment and will be printed to be analyzed manually
Laboratory The baseline analysis was performed on admission to the coronary care unit routine practice in this analysis is considered basal level of lipids total cholesterol and fractions on admission to hospital and the rest of the determinations the values of the day following fasting
Laboratory analysis at the end of the study will be conducted with the patient 12 hours of fasting before stopping the study medication
Analyses were performed in the hospital laboratory Crossing according to standard techniques
Assessing platelet aggregation was performed by aggregometry evaluated by turbidimetric method AggRAM Helena Laboratories Beaumont Texas USA
In tracking the value of blood pressure and heart rate were recorded at each visit as well as pill counts were also conducted to assess adherence
All data will be collected in a form designed for the study and stored in a database The data input to the system will be performed to minimize duplicate entry errors in the information
Follow up Follow-up visits will be conducted through interviews with one of the researchers
The monitoring scheme is as follows
7 days an additional 7 days
At 30 days an additional 15 days
At 3 months an additional 15 days
At 6 months an additional 15 days final visit Each visit will be an interview physical examination and ECG Counting capsules or pills to assess adherence is performed and a new supply of medication will be provided for the period until the next visit
At the final visit prior consultation with the researcher a blood with 12 hours of fasting to corresponding laboratory evaluations will be performed
Study Medication Study medication will be prepared in the hospital pharmacy Crossing protocolized according to procedures
Losses to follow up Patients who did not attend one or more follow-up visits will be excluded from study analysis of adhesion In all cases telephone contact will attempt to determine the occurrence of adverse events
Ethical Considerations Participants will be invited to participate in the study and will be explained in detail the objectives Be given a copy of the written informed consent for their participation and can decide evacuate their doubts about the protocol
The study was conducted according to the Declaration of Helsinki the guidelines of international harmonization and local laws In addition the protocol will be conducted in accordance with the guidelines for good clinical practice
They brighten at all times to patients the voluntary nature of participation in the study during the informed consent process At each visit will be asked verbally about his desire to continue in the study
Statistical Analysis Qualitative variables are described using numbers and percentages Continuous variables were described using means and standard deviations or medians and interquartile ranges if you have normal or non-normal distribution respectively Normality is determined by evaluating the quantile-quantile graphics and the Shapiro-Wilk test
Analyses were performed according to the intention-to-treat analysis of all patients according to the group to which they were assigned
The primary endpoint analysis was performed by Pearson chi2 test Further estimate the relative risk of adhesion in the experimental treatment group compared to the control group with their corresponding confidence intervals using a 2 x 2 table
The differences between groups in levels of cholesterol and blood pressure were made using Students t test
Subgroup analyzes according to age greater or less than the median sex education diabetes previous myocardial infarction and angioplasty was performed
All analyzes were performed two-tailed and a p value less than 005 was used to indicate statistical significance
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 11 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
All other medications that the patient receives will be determined and adjusted doses as determined by the treating physician
In patients receiving 100 mg day and atenolol 10 mg day of ramipril and require additional treatment to control blood pressure will recommend using thiazide diuretics calcium channel blockers and alpha-methyldopa in that order
All other medications that the patient receives will be determined and adjusted doses as determined by the treating physician
In patients receiving 100 mg day and atenolol 10 mg day of ramipril and require additional treatment to control blood pressure will recommend using thiazide diuretics calcium channel blockers and alpha-methyldopa in that order
The first supply of study medication will be held on discharge from hospital Patients will be referred for follow-up at 7 days with an additional 7 days a month 3 months and six months final visit For visits 2 3 and 4 be tolerated fifteen 15 days before considering that the patient did not attend the visit
Randomization After signing the informed consent patients will be randomized in a 11 ratio to receive study treatments
Randomization was carried out with lists of random numbers generated by computer with a block diagram of 4 and 6 Was also a scheme will use stratified by gender and diabetes
The mapping is done using consecutive sealed opaque envelopes To minimize the risk of predicting the next treatment the envelopes will be handled by the pharmacy staff
After signing the informed consent was informed pharmacy staff concerned in the study who will open the appropriate envelope and will be responsible for the preparation and supply of medication Appendix 1
Data Anthropometric data risk factors cardiovascular history blood pressure measurements and basal heart rate were collected All patients will have lab tests including blood count with platelet count fasting blood glucose creatinine urea electrolytes liver function tests total cholesterol cholesterol bound to high density lipoprotein HDL and low density LDL and triglycerides
Blood pressure and pulse It is measured on the left arm with the subject seated after 5 minutes of rest Three blood pressure measurements separated by a minute averaged realized and the last two discarding the first value Diastolic blood pressure will be recorded in the fifth Korotkoff sound Heart rate will be measured by averaging two measurements of 30 seconds rhythm in patients with atrial fibrillation two periods of 1 minute averaged These measurements were repeated at each follow-up visit
Electrocardiogram ECG were performed at baseline and follow-up with the subject in supine position after 5 minutes of rest All are made with automatic ECG 12-lead equipment and will be printed to be analyzed manually
Laboratory The baseline analysis was performed on admission to the coronary care unit routine practice in this analysis is considered basal level of lipids total cholesterol and fractions on admission to hospital and the rest of the determinations the values of the day following fasting
Laboratory analysis at the end of the study will be conducted with the patient 12 hours of fasting before stopping the study medication
Analyses were performed in the hospital laboratory Crossing according to standard techniques
Assessing platelet aggregation was performed by aggregometry evaluated by turbidimetric method AggRAM Helena Laboratories Beaumont Texas USA
In tracking the value of blood pressure and heart rate were recorded at each visit as well as pill counts were also conducted to assess adherence
All data will be collected in a form designed for the study and stored in a database The data input to the system will be performed to minimize duplicate entry errors in the information
Follow up Follow-up visits will be conducted through interviews with one of the researchers
The monitoring scheme is as follows
7 days an additional 7 days
At 30 days an additional 15 days
At 3 months an additional 15 days
At 6 months an additional 15 days final visit Each visit will be an interview physical examination and ECG Counting capsules or pills to assess adherence is performed and a new supply of medication will be provided for the period until the next visit
At the final visit prior consultation with the researcher a blood with 12 hours of fasting to corresponding laboratory evaluations will be performed
Study Medication Study medication will be prepared in the hospital pharmacy Crossing protocolized according to procedures
Losses to follow up Patients who did not attend one or more follow-up visits will be excluded from study analysis of adhesion In all cases telephone contact will attempt to determine the occurrence of adverse events
Ethical Considerations Participants will be invited to participate in the study and will be explained in detail the objectives Be given a copy of the written informed consent for their participation and can decide evacuate their doubts about the protocol
The study was conducted according to the Declaration of Helsinki the guidelines of international harmonization and local laws In addition the protocol will be conducted in accordance with the guidelines for good clinical practice
They brighten at all times to patients the voluntary nature of participation in the study during the informed consent process At each visit will be asked verbally about his desire to continue in the study
Statistical Analysis Qualitative variables are described using numbers and percentages Continuous variables were described using means and standard deviations or medians and interquartile ranges if you have normal or non-normal distribution respectively Normality is determined by evaluating the quantile-quantile graphics and the Shapiro-Wilk test
Analyses were performed according to the intention-to-treat analysis of all patients according to the group to which they were assigned
The primary endpoint analysis was performed by Pearson chi2 test Further estimate the relative risk of adhesion in the experimental treatment group compared to the control group with their corresponding confidence intervals using a 2 x 2 table
The differences between groups in levels of cholesterol and blood pressure were made using Students t test
Subgroup analyzes according to age greater or less than the median sex education diabetes previous myocardial infarction and angioplasty was performed
All analyzes were performed two-tailed and a p value less than 005 was used to indicate statistical significance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None