Clinical Trial Results:
Anglo-Scandinavian Cardiac Outcomes Trial; Post Trial Follow-Up Study
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Summary
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EudraCT number |
2010-023875-24 |
Trial protocol |
GB |
Global end of trial date |
30 May 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
08 Nov 2019
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First version publication date |
08 Nov 2019
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
CRO1777
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01499511 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Imperial College London
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Sponsor organisation address |
South Kensington Campus, London, United Kingdom, SW7 2AZ
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Public contact |
Judith A Mackay, Imperial College London, +44 2075941395, judith.mackay@imperial.nhs.uk
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Scientific contact |
Judith A Mackay, Imperial College London, +44 2075941395, judith.mackay@imperial.nhs.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
31 Jan 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
30 May 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
30 May 2015
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The principal research objective is to see whether there are long-term differences between the study treatments used in the original ASCOT study (atenolol-based vs perindopril-based treatment on blood pressure lowering, and atorvastatin versus placebo treatment on cholesterol lowering) in terms of cardiovascular disease (heart attacks, strokes and death from cardiovascular disease). Followup study without treatment
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Protection of trial subjects |
None
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
09 Jan 2012
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Scientific research | ||
Long term follow-up duration |
16 Years | ||
Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 1718
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Worldwide total number of subjects |
1718
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EEA total number of subjects |
1718
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
173
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From 65 to 84 years |
1417
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85 years and over |
128
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Recruitment
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Recruitment details |
ASCOT-10 is a follow-up study of surviving participants in the United Kingdom (UK)arm of the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) which was conducted between 2000 and 2005. | |||||||||||||||
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Pre-assignment
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Screening details |
It is follow up group from the ASCOT study, after 5.5 years treatment. | |||||||||||||||
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Period 1
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Period 1 title |
Overall (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | |||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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ASCOT participants amlodipine | |||||||||||||||
Arm description |
It is follow up group from the ASCOT study, after treatment with amlodipine for 5.5 years. No treatment only follow up. | |||||||||||||||
Arm type |
no intervention | |||||||||||||||
Investigational medicinal product name |
No product
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Other use
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Dosage and administration details |
no intervention
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Arm title
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ASCOT Participants Atenolol | |||||||||||||||
Arm description |
It is follow up group from the ASCOT study, after treatment with atenolol for 5.5 years. No treatment only follow up. | |||||||||||||||
Arm type |
No intervention | |||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Baseline characteristics reporting groups
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Reporting group title |
ASCOT participants amlodipine
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Reporting group description |
It is follow up group from the ASCOT study, after treatment with amlodipine for 5.5 years. No treatment only follow up. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
ASCOT Participants Atenolol
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Reporting group description |
It is follow up group from the ASCOT study, after treatment with atenolol for 5.5 years. No treatment only follow up. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
ASCOT participants amlodipine
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Reporting group description |
It is follow up group from the ASCOT study, after treatment with amlodipine for 5.5 years. No treatment only follow up. | ||
Reporting group title |
ASCOT Participants Atenolol
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Reporting group description |
It is follow up group from the ASCOT study, after treatment with atenolol for 5.5 years. No treatment only follow up. | ||
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End point title |
Morbidity after 16 years in patients recruited into the Anglo-Scandinavian Outcomes trial_non fatal myocardial infarction | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
16 years
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Statistical analysis title |
non fatal myocardial infarction | |||||||||
Comparison groups |
ASCOT participants amlodipine v ASCOT Participants Atenolol
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Number of subjects included in analysis |
1705
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
= 0.624 | |||||||||
Method |
ANOVA | |||||||||
Parameter type |
Cox proportional hazard | |||||||||
Confidence interval |
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End point title |
Morbidity After 16 Years in Patients Recruited Into the Anglo-Scandinavian Outcomes trial_non Fatal Stroke/TIA (Transient Ischaemic Attack) | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
16 years
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Statistical analysis title |
non Fatal Stroke/TIA (Transient Ischaemic Attack) | |||||||||
Comparison groups |
ASCOT participants amlodipine v ASCOT Participants Atenolol
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Number of subjects included in analysis |
1700
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
= 0.004 | |||||||||
Method |
ANOVA | |||||||||
Confidence interval |
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End point title |
Number of participants who have developed diabetes since the end of the ASCOT trial | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
16 years
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Statistical analysis title |
Diabetes | |||||||||
Comparison groups |
ASCOT participants amlodipine v ASCOT Participants Atenolol
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Number of subjects included in analysis |
1696
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
= 0.304 | |||||||||
Method |
ANOVA | |||||||||
Confidence interval |
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End point title |
Number of Participants Who Have Undergone Coronary/Peripheral Re-vascularisation Procedures Since the End of the ASCOT Trial | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
16 years
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Statistical analysis title |
Coronary/Peripheral Re-vascularisation Procedures | |||||||||
Comparison groups |
ASCOT participants amlodipine v ASCOT Participants Atenolol
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Number of subjects included in analysis |
1694
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
= 0.641 | |||||||||
Method |
ANOVA | |||||||||
Confidence interval |
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End point title |
Number of Participants Who Have Required Renal Replacement Therapy (Dialysis or Kidney Transplant) Since the End of the ASCOT Trial | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
16 years
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Statistical analysis title |
Required Renal Replacement Therapy | |||||||||
Comparison groups |
ASCOT participants amlodipine v ASCOT Participants Atenolol
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Number of subjects included in analysis |
1700
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
= 0.915 | |||||||||
Method |
ANOVA | |||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
16 years follow up
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
10
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Reporting groups
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Reporting group title |
ASCOT participants amlodipine
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Reporting group description |
It is follow up group from the ASCOT study, after treatment with amlodipine for 5.5 years. No treatment only follow up. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
ASCOT Participants Atenolol
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Reporting group description |
It is follow up group from the ASCOT study, after treatment with atenolol for 5.5 years. No treatment only follow up. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
