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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023875-24 | EudraCT Number |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.ASCOT's results showed substantial cardiovascular benefit from: 1) the use of a cholesterol lowering drug (atorvastatin) compared to placebo, and 2) the use of a blood-pressure lowering strategy based on amlodipine when compared to a strategy based on atenolol. ASCOT-10 will test the hypothesis that the ASCOT subjects who originally received Atorvastatin and those who received amlodipine based treatment will continue to show a cardiovascular benefit relative to those who did not, even though all the subjects have had access to optimal treatment in the interim.
Study investigators will have access to information about ASCOT patients from their study centre who have died since the end of the ASCOT study in 2005. Of the 8580 ASCOT patients from the United Kingdom, 7300 were flagged with The Information Centre for Health and Social Care at the end of the trial in 2005.This flagging process was re-activated in 2010 so that all deaths and incident cancers relating to these patients are now sent every three months to the ASCOT-10 co-ordinating centre. These results are identified by the ASCOT study number, with all personal data removed. These deceased patient numbers will be communicated to the participating sites so that the trial centre staff will not contact their families.
An attempt will be made to contact all remaining patients from the participating UK ASCOT sites.
Initial contact will be made via the general practitioner (GP) surgery. If the GP can provide up-to-date contact details and feels that it is appropriate to contact the patient, patients will then be sent an introductory letter, a patient information sheet, a consent form and a health questionnaire.
They will be asked to complete a 'tick-box' form given the following options:
They will be asked to complete this form, sign, date and return in a pre-paid envelope to their trial centre. This form will be used as the consent form for the questionnaire part of the study.
They will also be asked to complete a simple health questionnaire. This will collect information on any health problems experienced since the end of the ASCOT trial (in particular about heart attacks and strokes/mini-strokes), as well as information on any hospital admissions during this period and current medication. In addition, information about current weight, exercise, alcohol consumption, smoking and general quality of life will be collected. Patients will be asked to return their completed questionnaire, along with their consent/reply form, to their local trial centre.
If the study team have not received a response within four weeks, a further reminder letter will be sent. If no response has been obtained after a further four weeks, a final attempt will be made to contact the patient by letter or telephone call.
10% of the study population from each trial centre, who will be chosen at random, will be invited to attend their trial centre for a single clinic visit. Further informed consent following discussion with member(s) of the study team will be obtained. During the clinic visit the questionnaire will be reviewed and several further measurements will be taken as follows:
Every effort will be taken to contact patients who have moved since the ASCOT study closed and for whom no contact details are available. This may be done by health service tracking services, where available, or via Primary Care Trusts (PCTs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASCOT participants amlodipine | It is follow up group from the ASCOT study, after treatment with amlodipine for 5.5 years. No treatment only follow up. | ||
| ASCOT participants atenolol | 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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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Have Died From Cardiovascular Disease Since the End of the ASCOT Study | Number of participants who have died from cardiovascular disease since the end of the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Armstudy | 16 years |
| Number of Participants With Non Fatal Myocardial Infarction | Morbidity of non fatal myocardial infarction after 16 years in patients recruited into the Anglo-Scandinavian Outcomes trial with two groups | 16 years |
| Number of Participants With Non Fatal Stroke/TIA (Transient Ischaemic Attack) | Non fatal stroke and TIA (Transient Ischaemic Attack) morbidity after 16 years in patients recruited into the Anglo-Scandinavian Outcomes trial | 16 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Have Developed Diabetes Since the End of the ASCOT Trial | Diabetes morbidity after 16 years in patients recruited into the Anglo-Scandinavian Outcomes trial | 16 years |
| Number of Participants Who Have Undergone Coronary/Peripheral Re-vascularisation Procedures Since the End of the ASCOT Trial |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who participated in the Anglo-Scandinavian Cardiac Outcomes Trial in the UK
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| Name | Affiliation | Role |
|---|---|---|
| Judith A Mackay, MBBS PhD MRCP | Imperial College Healthcare NHS Trust | Study Director |
| Peter S Sever, MBChB FRCP PhD | Imperial College London | Principal Investigator |
| Simon M Thom, MBBS MD FRCP | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Centre for Circulatory Health | London | W2 1LA | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16154016 | Background | Dahlof B, Sever PS, Poulter NR, Wedel H, Beevers DG, Caulfield M, Collins R, Kjeldsen SE, Kristinsson A, McInnes GT, Mehlsen J, Nieminen M, O'Brien E, Ostergren J; ASCOT Investigators. Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA): a multicentre randomised controlled trial. Lancet. 2005 Sep 10-16;366(9489):895-906. doi: 10.1016/S0140-6736(05)67185-1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ASCOT Participants Amlodipine | It is follow up group from the ASCOT study, after treatment with amlodipine for 5.5 years. No treatment only follow up. |
| FG001 | ASCOT Participants Atenolol | It is follow up group from the ASCOT study, after treatment with atenolol for 5.5 years. No treatment only follow up. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All patients recruited into long term follow up
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| ID | Title | Description |
|---|---|---|
| BG000 | ASCOT Participants Amlodipine | It is follow up group from the ASCOT study, after treatment with amlodipine for 5.5 years. No treatment only follow up. |
| BG001 | ASCOT Participants Atenolol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Have Died From Cardiovascular Disease Since the End of the ASCOT Study | Number of participants who have died from cardiovascular disease since the end of the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Armstudy | Data not collected | Posted | 16 years |
|
|
16 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ASCOT Participants Amlodipine | Follow up study for amlodipine, no intervention. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injuries | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment | after fall from bicycle |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Collapse | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Peter Sever | Imperial College London | 02075941100 | p.sever@imperial.ac.uk |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D003920 | Diabetes Mellitus |
| D009203 | Myocardial Infarction |
| D020521 | Stroke |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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Plasma to be stored for future measurement of biochemical markers of cardiovascular disease
Number of participants who have undergone coronary/peripheral re-vascularisation procedures since the end of the ASCOT trial, follow up |
| 16 years |
| Number of Participants Who Have Required Renal Replacement Therapy (Dialysis or Kidney Transplant) Since the End of the ASCOT Trial | Number of participants who have required renal replacement therapy (dialysis or kidney transplant) since the end of the ASCOT trial, follow up | 16 years |
| Number of Participants Who Have Experienced a Transient Ischaemic Attack (TIA) Since the End of the ASCOT Trial | 16 years |
It is follow up group from the ASCOT study, after treatment with atenolol for 5.5 years. No treatment only follow up.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Primary | Number of Participants With Non Fatal Myocardial Infarction | Morbidity of non fatal myocardial infarction after 16 years in patients recruited into the Anglo-Scandinavian Outcomes trial with two groups | 13 participants had missing data | Posted | Count of Participants | Participants | 16 years |
|
|
|
|
| Primary | Number of Participants With Non Fatal Stroke/TIA (Transient Ischaemic Attack) | Non fatal stroke and TIA (Transient Ischaemic Attack) morbidity after 16 years in patients recruited into the Anglo-Scandinavian Outcomes trial | 18 participants had missing data | Posted | Count of Participants | Participants | 16 years |
|
|
|
|
| Secondary | Number of Participants Who Have Developed Diabetes Since the End of the ASCOT Trial | Diabetes morbidity after 16 years in patients recruited into the Anglo-Scandinavian Outcomes trial | 22 participants had missing data | Posted | Count of Participants | Participants | 16 years |
|
|
|
|
| Secondary | Number of Participants Who Have Undergone Coronary/Peripheral Re-vascularisation Procedures Since the End of the ASCOT Trial | Number of participants who have undergone coronary/peripheral re-vascularisation procedures since the end of the ASCOT trial, follow up | 24 participants had missing data | Posted | Count of Participants | Participants | 16 years |
|
|
|
|
| Secondary | Number of Participants Who Have Required Renal Replacement Therapy (Dialysis or Kidney Transplant) Since the End of the ASCOT Trial | Number of participants who have required renal replacement therapy (dialysis or kidney transplant) since the end of the ASCOT trial, follow up | 18 participants had missing data | Posted | Count of Participants | Participants | 16 years |
|
|
|
|
| Secondary | Number of Participants Who Have Experienced a Transient Ischaemic Attack (TIA) Since the End of the ASCOT Trial | Combined together with 3. primary outcome, it was not possible to differentiate between data collected for TIAs and Non fatal stroke | Posted | 16 years |
|
|
| 1 |
| 885 |
| 2 |
| 885 |
| 4 |
| 885 |
| EG001 | ASCOT Participants Atenolol | Follow up study for atenolol, no intervention. | 0 | 833 | 0 | 833 | 1 | 833 |
|
| Ischaemic stroke | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Stomach cramps | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| High blood pressure | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Alcohol dependence withdrawal | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
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| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |