Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000504
Status:
COMPLETED
Last Update Posted:
2012-04-27
First Post:
1999-10-27
Brief Title:
Cardiac Arrhythmia Pilot Study CAPS
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To compare the effectiveness of various drugs and drug combinations in suppressing complex ventricular arrhythmias and to evaluate their safety
Detailed Description:
BACKGROUND
Epidemiologic studies had indicated that complex ventricular premature beats made an independent contribution to risk of sudden death in survivors of a myocardial infarction MI and did not appear to be merely a reflection of their association with relatively severe myocardial damage The potential for reduction in mortality by identification and administration of drugs capable of safely suppressing ventricular arrhythmias was tremendous In 1982 there was incomplete knowledge regarding which types of ventricular arrhythmias responded to various kinds of drugs A pilot study of antiarrhythmic agents helped clarify this issue
Numerous antiarrhythmic agents with differing pharmacologic properties and side effects had been shown to suppress ventricular arrhythmias It had also been postulated that antiarrhythmics might raise an individuals threshold for experiencing ventricular fibrillation There had been several published reports of large at least l00 patients long-term clinical trials of antiarrhythmic agents in post-MI patients None of these had yielded statistically significant results using mortality as the response variable This might have been due to incorrect drug selection inadequate sample size inappropriate choice of patients or the lack of impact of arrhythmia treatment on mortality
Due to incomplete knowledge as to which drugs and combinations of drugs were most effective it was considered to be premature to undertake a full scale trial in 1981-1982 However the public health problem was of sufficient magnitude to warrant a pilot study to learn more about the efficacy and safety of various antiarrhythmic drugs singly or in combination
The protocol planning phase began in October l982 Patient recruitment started in July l983 and ended in the summer of 1985 Each patient was followed for one year
DESIGN NARRATIVE
Randomized double-blind fixed sample A total of 502 patients were randomly assigned to 5 treatment groups consisting of encainide ethmozine flecainide imipramine and placebo
Epidemiologic studies had indicated that complex ventricular premature beats made an independent contribution to risk of sudden death in survivors of a myocardial infarction MI and did not appear to be merely a reflection of their association with relatively severe myocardial damage The potential for reduction in mortality by identification and administration of drugs capable of safely suppressing ventricular arrhythmias was tremendous In 1982 there was incomplete knowledge regarding which types of ventricular arrhythmias responded to various kinds of drugs A pilot study of antiarrhythmic agents helped clarify this issue
Numerous antiarrhythmic agents with differing pharmacologic properties and side effects had been shown to suppress ventricular arrhythmias It had also been postulated that antiarrhythmics might raise an individuals threshold for experiencing ventricular fibrillation There had been several published reports of large at least l00 patients long-term clinical trials of antiarrhythmic agents in post-MI patients None of these had yielded statistically significant results using mortality as the response variable This might have been due to incorrect drug selection inadequate sample size inappropriate choice of patients or the lack of impact of arrhythmia treatment on mortality
Due to incomplete knowledge as to which drugs and combinations of drugs were most effective it was considered to be premature to undertake a full scale trial in 1981-1982 However the public health problem was of sufficient magnitude to warrant a pilot study to learn more about the efficacy and safety of various antiarrhythmic drugs singly or in combination
The protocol planning phase began in October l982 Patient recruitment started in July l983 and ended in the summer of 1985 Each patient was followed for one year
DESIGN NARRATIVE
Randomized double-blind fixed sample A total of 502 patients were randomly assigned to 5 treatment groups consisting of encainide ethmozine flecainide imipramine and placebo
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: