ID

43980

Beschreibung

The purpose of the trial is to determine if extended-release dipyridamole + aspirin [Aggrenox, Asasa ntin] is superior to clopidogrel [Plavix], and if telmisartan [Micardis, Gliosartan, Kinzal, Kinzalm ono, Predxal, Pritor, Samertan, Telmisartan] is superior to placebo, in the presence of background antihypertensive therapy, in prevention of a second stroke in patients who have recently suffered a stroke and therefore are at high risk of suffering another one. Blood Pressure: Seated blood pressures will consist of the average of three consecutive measurements taken approximately two minutes apart, and round to the nearest whole numbers. When possible blood pressure should be taken using the automated device provided to the site by the sponsor. It is encouraged that the blood pressure is always taken in the sitting position, however for patient who cannot sit, supine bolded pressure is acceptable. Documentation process: This form ist to be obtained 7 days post-randomization at Visit 1A

Stichworte

Versionen (3)
  1. 15.02.17 15.02.17 -
  2. 20.02.17 20.02.17 -
  3. 20.09.21 20.09.21 -
Hochgeladen am

20. September 2021

DOI

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Creative Commons BY-NC 3.0
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Trial Medication Compliance PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

Englisch

Trial Medication Compliance PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

1 Formulare  
Trial Medication Compliance
Beschreibung

Trial Medication Compliance

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C1321605
1. Date of first intake of trial medication (dd mon yy)
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0011008
Blood Pressure Measurement
Beschreibung

Blood Pressure Measurement

Alias
UMLS CUI-1
C0005824
2. Was the patient hospitalized at randomization?
Beschreibung

Hospitalized at randomization

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0019993
If Yes
Beschreibung

If Yes

Alias
UMLS CUI-1
C1521902
Day post randomization
Beschreibung

Day

Datentyp

integer

Alias
UMLS CUI [1]
C0439228
Blood pressure (prior to morning dose of trial medications) systolic
Beschreibung

Systolic Blood Pressure

Datentyp

float

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure (prior to morning dose of trial medications) diastolic
Beschreibung

Diastolic Blood Pressure

Datentyp

float

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse Rate
Beschreibung

Pulse Rate

Datentyp

float

Maßeinheiten
  • beats/minute
Alias
UMLS CUI [1]
C0232117
beats/minute
Position
Beschreibung

Position

Datentyp

integer

Alias
UMLS CUI [1]
C1828063
Blood Pressure Measurement
Beschreibung

Blood Pressure Measurement

Alias
UMLS CUI-1
C0005823
4. If NO please contact the patients physician by phone and try to obtain a blood pressure measurement approximately 1 week after treatment start, and complete questions 5-11.
Beschreibung

If NO

Datentyp

text

5. Date of blood pressure measurement (dd-mon-yy)
Beschreibung

Date of measurement

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0242485
6. Blood pressure systolic after 5 minutes sitting/supine
Beschreibung

Systolic Blood Pressure

Datentyp

float

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
6. Blood pressure diastolic after 5 minutes sitting/supine
Beschreibung

Diastolic Blood Pressure

Datentyp

float

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
7. Pulse Rate
Beschreibung

Pulse Rate

Datentyp

float

Maßeinheiten
  • beats/minute
Alias
UMLS CUI [1]
C0232117
beats/minute
8. Blood Pressure Position
Beschreibung

Blood Pressure Position

Datentyp

integer

Alias
UMLS CUI [1]
C1828063
9. Who took patient´s blood pressure:
Beschreibung

Who took patient´s blood pressure

Datentyp

integer

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C1705848
If "Other" specify:
Beschreibung

Other

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1521902
10. Source of blood pressure information:
Beschreibung

Source of blood pressure information

Datentyp

text

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C3146298
11. Has patient been hospitalized since randomization? If YES, please complete the Hospitalization report form.
Beschreibung

Hospitalized since randomization

Datentyp

boolean

Alias
UMLS CUI [1]
C0019993
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Ähnliche Modelle

Trial Medication Compliance PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Trial Medication Compliance
C0013227 (UMLS CUI-1)
C1321605 (UMLS CUI-2)
Date
Item
1. Date of first intake of trial medication (dd mon yy)
date
C0013227 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Blood Pressure Measurement
C0005824 (UMLS CUI-1)
Hospitalized at randomization
Item
2. Was the patient hospitalized at randomization?
boolean
C0034656 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
Item Group
If Yes
C1521902 (UMLS CUI-1)
Item
Day post randomization
integer
C0439228 (UMLS CUI [1])
Day
Code List
Day post randomization
CL Item
Day 2 post randomization (1)
CL Item
Day 3 post randomization (2)
CL Item
Day 4 post randomization (3)
CL Item
Day 5 post randomization (4)
CL Item
Day 6 post randomization (5)
CL Item
Day 7 post randomization (6)
Systolic Blood Pressure
Item
Blood pressure (prior to morning dose of trial medications) systolic
float
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Blood pressure (prior to morning dose of trial medications) diastolic
float
C0428883 (UMLS CUI [1])
Pulse Rate
Item
Pulse Rate
float
C0232117 (UMLS CUI [1])
Item
Position
integer
C1828063 (UMLS CUI [1])
Position
Code List
Position
CL Item
Sitting (1)
CL Item
Supine (2)
Item Group
Blood Pressure Measurement
C0005823 (UMLS CUI-1)
If NO
Item
4. If NO please contact the patients physician by phone and try to obtain a blood pressure measurement approximately 1 week after treatment start, and complete questions 5-11.
text
Date of measurement
Item
5. Date of blood pressure measurement (dd-mon-yy)
date
C0011008 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
Systolic Blood Pressure
Item
6. Blood pressure systolic after 5 minutes sitting/supine
float
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
6. Blood pressure diastolic after 5 minutes sitting/supine
float
C0428883 (UMLS CUI [1])
Pulse Rate
Item
7. Pulse Rate
float
C0232117 (UMLS CUI [1])
Item
8. Blood Pressure Position
integer
C1828063 (UMLS CUI [1])
Blood Pressure Position
Code List
8. Blood Pressure Position
CL Item
Sitting (1 )
CL Item
Supine (2 )
Item
9. Who took patient´s blood pressure:
integer
C0005823 (UMLS CUI [1,1])
C1705848 (UMLS CUI [1,2])
Who took patient´s blood pressure
Code List
9. Who took patient´s blood pressure:
CL Item
Physician, nurse or health care professional (1)
CL Item
Patient/Caregiver using a home blood pressure measurement device (2)
CL Item
Other (3)
Other
Item
If "Other" specify:
text
C0205394 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item
10. Source of blood pressure information:
text
C0005823 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Source of blood pressure information
Code List
10. Source of blood pressure information:
CL Item
Patient only (0)
CL Item
Third party, friend or relative of patient (1)
CL Item
Patient came to study centre (2)
CL Item
Other physican or health care professional (3)
CL Item
Unable to obtain measurement (4)
Hospitalized since randomization
Item
11. Has patient been hospitalized since randomization? If YES, please complete the Hospitalization report form.
boolean
C0019993 (UMLS CUI [1])
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