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Trial record 39 of 584 for:    ESCITALOPRAM

Responses of Myocardial Ischemia to Escitalopram Treatment (REMIT)

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ClinicalTrials.gov Identifier: NCT00574847
Recruitment Status : Completed
First Posted : December 17, 2007
Results First Posted : August 5, 2015
Last Update Posted : August 5, 2015
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Myocardial Ischemia
Interventions Drug: Escitalopram
Drug: Placebo
Enrollment 127
Recruitment Details We screened all patients with Coronary Heart Disease (CHD) who visited Duke cardiology clinics. Patients 21 years or older were eligible to participate if they had CHD, as documented by angiographic findings of coronary artery stenosis of 70% or greater, history of MI, or history of cardiac revascularization.
Pre-assignment Details 25527 underwent initial screening. 22833 excluded due to reasons including no CHD, atrial fibrillation/arrhythmia, psychiatric disorder, and LVEF less than 30%. 2294 did not provide consent. 65 excluded due to medical conditions. 203 excluded due to no MSIMI or inability to undergo mental stress testing. 5 more declined to undergo randomization.
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed. Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Period Title: Overall Study
Started 64 63
Completed 56 56
Not Completed 8 7
Reason Not Completed
Adverse Event             2             0
Death             1             0
Withdrawal by Subject             2             2
Physician Decision             1             0
Did not receive medication (declined)             2             5
Arm/Group Title Escitalopram Placebo Total
Hide Arm/Group Description Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed. Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed. Total of all reporting groups
Overall Number of Baseline Participants 64 63 127
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 64 participants 63 participants 127 participants
66.5  (9.3) 61.4  (11.5) 64.0  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 63 participants 127 participants
Female
11
  17.2%
15
  23.8%
26
  20.5%
Male
53
  82.8%
48
  76.2%
101
  79.5%
History of Depression  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 64 participants 63 participants 127 participants
11 10 21
1.Primary Outcome
Title Percentage of Participants With an Absence of Mental Stress-induced Myocardial Ischemia (MSIMI) During the 3 Mental Stressors
Hide Description MSIMI is defined by the following: compared to rest, 1) any development of new abnormal wall motion; 2) reduction of LVEF 8% and/or; 3) deviation (depression or elevation) of ST-segment of ECG in 2 or more leads lasting for 3 consecutive beats, occurring during at least one of the 3 mental stress tasks.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT)
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:
Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Overall Number of Participants Analyzed 64 63
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
34.2
(31.6 to 36.8)
17.5
(15.4 to 19.6)
2.Primary Outcome
Title Percentage of Participants With Overall Mental Stress-induced Myocardial Ischemia (MSIMI)
Hide Description MSIMI is defined by the following: compared to rest, 1) any development of new abnormal wall motion; 2) reduction of LVEF 8% and/or; 3) deviation (depression or elevation) of ST-segment of ECG in 2 or more leads lasting for 3 consecutive beats, occurring during at least one of the 3 mental stress tasks.
Time Frame week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who completed.
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:
Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Overall Number of Participants Analyzed 56 56
Measure Type: Number
Unit of Measure: percentage of participants
66.1 83.9
3.Secondary Outcome
Title Mental Stress Induced Change of Systolic Blood Pressure
Hide Description Blood pressure will be measured the last 3 minutes of the 20 minute calibration period (resting), every minute during the 3 minutes mental stress testing, the last 3 minutes of the 6 minute rest periods between mental stress testing, and every minute during and after the physical stress testing with an automatic oscillometric blood pressure monitor (Quinton Electronics). Mental Stress Induced Change of Systolic Blood Pressure will be calculated by taking the mean of the mental stress systolic blood pressure measurements minus the resting Systolic blood pressure. End point values adjusted for baseline values age and sex.
Time Frame Baseline, week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, 9 subjects excluded from analysis due to missing data.
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:
Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Overall Number of Participants Analyzed 62 56
Mean (95% Confidence Interval)
Unit of Measure: mm Hg
19.3
(16.7 to 22.0)
23.6
(20.8 to 26.4)
4.Secondary Outcome
Title Mental Stress Induced Change of Diastolic Blood Pressure
Hide Description Blood pressure will be measured the last 3 minutes of the 20 minute calibration period (resting), every minute during the 3 minutes mental stress testing, the last 3 minutes of the 6 minute rest periods between mental stress testing, and every minute during and after the physical stress testing with an automatic oscillometric blood pressure monitor (Quinton Electronics). Mental Stress Induced Change of Diastolic Blood Pressure will be calculated by taking the mean of the mental stress Diastolic blood pressure measurements minus the resting Diastolic blood pressure. End point values adjusted for baseline values age and sex.
Time Frame Baseline, week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, 9 subjects excluded from the analysis due to missing data.
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:
Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Overall Number of Participants Analyzed 62 56
Mean (95% Confidence Interval)
Unit of Measure: mm Hg
11.4
(9.5 to 13.4)
12.2
(10.1 to 14.2)
5.Secondary Outcome
Title Percentage of Participants With Adverse Events
Hide Description [Not Specified]
Time Frame Baseline to week 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:
Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Overall Number of Participants Analyzed 64 63
Measure Type: Number
Unit of Measure: percentage of participants
71.9 44.4
6.Secondary Outcome
Title Beck Depression Inventory
Hide Description The Beck Depression Inventory II (BDI-II) is a 21 question, self-administered measure of depressive symptoms. Score range, 0 to 63 (higher score=greater severity of depressive symptoms). End point values adjusted for baseline values age and sex.
Time Frame 6 week
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:
Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Overall Number of Participants Analyzed 64 63
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
7.4
(6.3 to 8.6)
7.0
(5.8 to 8.2)
7.Secondary Outcome
Title Mental Stress Induced Change in Heart Rate
Hide Description

A standard 12-lead Electrocardiograph (ECG) will be recorded at 1-minute intervals during the last 3 minutes of each rest period, the 3 minutes of the mental stress testing, and during exercise testing. Heart rate will be determined from the ECGs.

Mental Stress Induced Change in heart rate will be calculated by taking the mean of the mental stress heart rate measurements minus the resting heart rate measurements. End point values adjusted for baseline values age and sex.

Time Frame baseline, 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, 10 subjects excluded from analysis due to missing data.
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:
Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Overall Number of Participants Analyzed 61 56
Mean (95% Confidence Interval)
Unit of Measure: beats/minute
6.34
(5.0 to 7.7)
9.1
(7.8 to 10.5)
8.Secondary Outcome
Title 5HTT, Serotonin Transporter Protein
Hide Description End point values adjusted for baseline values age and sex.
Time Frame week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, 29 subjects excluded from analysis due to missing data.
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:
Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Overall Number of Participants Analyzed 48 50
Mean (95% Confidence Interval)
Unit of Measure: fmol/mg
139.7
(126.1 to 153.4)
160.4
(147.0 to 173.7)
9.Secondary Outcome
Title Platelet Serotonin Binding Affinity Kd_100
Hide Description End point values adjusted for baseline values age and sex.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, 27 subjects were excluded from analysis due to missing data.
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:
Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Overall Number of Participants Analyzed 50 50
Mean (95% Confidence Interval)
Unit of Measure: nM
4202.4
(3328.6 to 5076.2)
210.1
(0.0 to 1083.9)
10.Secondary Outcome
Title Perceived Stress Scale
Hide Description Score range, 10 to 50 (higher score = greater levels of perceived stress). End point values adjusted for baseline values age and sex.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:
Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Overall Number of Participants Analyzed 64 63
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
21.4
(20.3 to 22.5)
21.8
(20.6 to 22.9)
11.Secondary Outcome
Title Cook-Medley Hostility (Ho) Scale
Hide Description Score ranges: hostility, 0 to 27 (higher score=greater levels of hostility)/ End point values adjusted for baseline values age and sex.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, 1 subject excluded from analysis due to missing data.
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:
Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Overall Number of Participants Analyzed 64 62
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
9.9
(9.1 to 10.7)
10.3
(9.5 to 11.1)
12.Secondary Outcome
Title Cook-Medley Hostility (Ho) Hostile Affect Sub-scale
Hide Description hostile affect, 0 to 5 (higher score=greater levels of hostile affect). End point values adjusted for baseline values age and sex.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, 1 subject excluded from analysis due to missing data.
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:
Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Overall Number of Participants Analyzed 64 62
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
1.6
(1.3 to 1.8)
1.8
(1.6 to 2.1)
13.Secondary Outcome
Title Spielberger State-Trait Anxiety Inventory Scales (STAI)
Hide Description STAI measures anxiety. The questionnaire asks the patients how they feel and allows them to respond on a frequency scale that ranges from 1(not at all) to 4(almost always/very much so). Scores range from 20-80 and the higher the score the greater the anxiety level. This applies to both the Trait and State scales. End point values adjusted for baseline values age and sex.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:
Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Overall Number of Participants Analyzed 64 63
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Trait
31.2
(29.7 to 32.6)
32.0
(30.5 to 33.4)
State
27.9
(26.4 to 29.4)
29.5
(28.0 to 31.1)
14.Secondary Outcome
Title Exercise Stressed-induced Myocardial Ischemia (ESIMI)
Hide Description End point values adjusted for baseline values age and sex.
Time Frame 6 week
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, 7 subject excluded from analysis due to missing data.
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:
Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Overall Number of Participants Analyzed 59 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of change
45.8
(36.6 to 55.0)
52.5
(43.3 to 61.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed. Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
All-Cause Mortality
Escitalopram Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Escitalopram Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   3/64 (4.69%)   1/63 (1.59%) 
Cardiac disorders     
Death  1/64 (1.56%)  0/63 (0.00%) 
unstable angina  1/64 (1.56%)  1/63 (1.59%) 
Nervous system disorders     
Confusion, Hallucination  1/64 (1.56%)  0/63 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Escitalopram Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   46/64 (71.88%)   28/63 (44.44%) 
Cardiac disorders     
irregular heartbeat  0/64 (0.00%)  2/63 (3.17%) 
Gastrointestinal disorders     
constipation  18/64 (28.13%)  11/63 (17.46%) 
General disorders     
fatigue  19/64 (29.69%)  9/63 (14.29%) 
Infections and infestations     
sinusitis  1/64 (1.56%)  0/63 (0.00%) 
Musculoskeletal and connective tissue disorders     
cramping in legs  3/64 (4.69%)  2/63 (3.17%) 
Nervous system disorders     
CNS symptom  17/64 (26.56%)  13/63 (20.63%) 
Reproductive system and breast disorders     
sexual dysfunction  10/64 (15.63%)  4/63 (6.35%) 
Skin and subcutaneous tissue disorders     
burning sensation  1/64 (1.56%)  0/63 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Wei Jiang, MD
Organization: Duke University Medical Center
Phone: 919-668-0762
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00574847     History of Changes
Other Study ID Numbers: Pro00009555
R01HL085704-01 ( U.S. NIH Grant/Contract )
8640-07-8R1ER ( Other Identifier: Duke legacy protocol number )
First Submitted: December 12, 2007
First Posted: December 17, 2007
Results First Submitted: June 11, 2015
Results First Posted: August 5, 2015
Last Update Posted: August 5, 2015