Acute Coronary SyndromeNCT01162187
Secondary Prevention in Acute Coronary Syndromes: A CALIBER Study
An observational study of Acute Coronary Syndrome, run by University College, London.
Trial summary
All contemporary guidelines for secondary prevention in acute coronary syndromes recommend a combination of aspirin, beta-blockers, ACE-inhibitors and statins. Yet underutilisation of these drugs is common. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 400,000 participants
- Where
- No sites listed yet
- Study dates
- Jul 2003to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals with data entered into the Myocardial Ischaemia National Audit Project (MINAP) database in England and Wales.
Who may be able to join
- Individuals with Acute Coronary Syndrome who have been registered with the MINAP database.
Who cannot join
- None
About this study
Official title: Secondary Prevention in Acute Coronary Syndromes: Long-term Survival in Relation to the Number and Combination of Evidence-based Therapies Prescribed Prior to Discharge (a CALIBER Study)
All contemporary guidelines for secondary prevention in acute coronary syndromes recommend a combination of aspirin, beta-blockers, ACE-inhibitors and statins. Yet underutilisation of these drugs is common. We do not know in detail what drives underutilisation, nor what its long term consequences are for survival after discharge from hospital. Also unknown is whether potential adverse effects of underutilisation are the same for individual secondary prevention drugs.
This study will assess the impact of secondary prevention underutilisation on survival.
Read the detailed description
Using information from an England and Wales audit of acute coronary syndromes (the Myocardial Ischaemia National Audit Project (MINAP)) we aim to assess:
(i) Survival from first time MINAP-registered event to death as a function of secondary prevention medications: To what degree do the effects of medications (assumed equal, independent and additive) relate to patient survival? Is there evidence of a differential effect of discharge medications? (ii) (a) Survival from first time MINAP-registered event to death or second time MINAP-registered event as a function of secondary prevention medications: To what degree do the effects of medications (assumed equal, independent and additive) relate to competing risks? Is there evidence of a differential effect of discharge medications? (b) Survival from first time MINAP-registered event to death or second time MINAP-registered phenotyped as STEMI, NSTEMI or Unstable Angina. To what degree do the effects of medications (assumed equal, independent and additive) relate to competing risks? Is there evidence of a differential effect of discharge medications? (iii) What impact would ensuring all medication is taken have on event free survival?
This study is part of the CALIBER (Cardiovascular disease research using linked bespoke studies and electronic records) programme funded over 5 years from the NIHR and Wellcome Trust. The central theme of the CALIBER research is linkage of the Myocardial Ischaemia National Audit Project (MINAP) with primary care (GPRD) and other resources. The overarching aim of CALIBER is to better understand the aetiology and prognosis of specific coronary phenotypes across a range of causal domains, particularly where electronic records provide a contribution beyond traditional studies. CALIBER has received both Ethics approval (ref 09/H0810/16) and ECC approval (ref ECC 2-06(b)/2009 CALIBER dataset).
- Conditions
- Acute Coronary Syndrome
- Keywords
- secondary prevention, aspirin, beta blocker, ACE inhibitor, statin, acute coronary syndrome, myocardial infarction, unstable angina, trends
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction, Angina, Unstable
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Mortality as tracked by the Office for National Statistics
Measured: Due to follow up an average of 3 years.
Secondary outcomes (1)
Competing risks between acute coronary syndrome phenotypes
Stable Angina, Unstable Angina, STEMI and NSTEMI will be treated both as startpoints and endpoints in transitions between phenotypes.
Measured: Due to follow up an average of 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2010 (estimated)
- Study startJul 2003
- Primary completionJun 2010 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Barts & The London NHS Trust, University of Leicester
- Investigators
- Owen M Nicholas, PhD, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01162187
- Sponsor's protocol ID
- CALIBER-09-02
- Status last verified
- Jul 2010
- First submitted
- 1 Jul 2010
- Last updated
- 14 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
National Collaborating Centre for Primary Care (UK). Post Myocardial Infarction: Secondary Prevention in Primary and Secondary Care for Patients Following a Myocardial Infarction [Internet]. London: Royal College of General Practitioners (UK); 2007 May. Available from http://www.ncbi.nlm.nih.gov/books/NBK49343/
PubMed 21290635Goodman SG, Huang W, Yan AT, Budaj A, Kennelly BM, Gore JM, Fox KA, Goldberg RJ, Anderson FA Jr; Expanded Global Registry of Acute Coronary Events (GRACE2) Investigators. The expanded Global Registry of Acute Coronary Events: baseline characteristics, management practices, and hospital outcomes of patients with acute coronary syndromes. Am Heart J. 2009 Aug;158(2):193-201.e1-5. doi: 10.1016/j.ahj.2009.06.003.
PubMed 19619694Chew DP, Anderson FA, Avezum A, Eagle KA, FitzGerald G, Gore JM, Dedrick R, Brieger D; GRACE Investigators. Six-month survival benefits associated with clinical guideline recommendations in acute coronary syndromes. Heart. 2010 Aug;96(15):1201-6. doi: 10.1136/hrt.2009.184853. Epub 2010 Jun 7.
PubMed 20530127Bramlage P, Messer C, Bitterlich N, Pohlmann C, Cuneo A, Stammwitz E, Tebbenjohanns J, Gohlke H, Senges J, Tebbe U. The effect of optimal medical therapy on 1-year mortality after acute myocardial infarction. Heart. 2010 Apr;96(8):604-9. doi: 10.1136/hrt.2009.188607. Epub 2010 Mar 29.
PubMed 20353936
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Prevention in Acute Coronary Syndromes: Long-term Survival in Relation to the Number and Combination of Evidence-based Therapies Prescribed Prior to Discharge (a CALIBER Study)
- ClinicalTrials.gov ID
- NCT01162187
- Acronym / sponsor ID
- CALIBER-09-02
- Conditions
- Acute Coronary Syndrome
- Keywords
- secondary prevention, aspirin, beta blocker, ACE inhibitor, statin, acute coronary syndrome, myocardial infarction, unstable angina
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400,000 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Barts & The London NHS Trust, University of Leicester
- Study start
- Jul 2003
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 14 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
All contemporary guidelines for secondary prevention in acute coronary syndromes recommend a combination of aspirin, beta-blockers, ACE-inhibitors and statins. Yet underutilisation of these drugs is common. We do not know in detail what drives underutilisation, nor what its long term consequences are for survival after discharge from hospital. Also unknown is whether potential adverse effects of underutilisation are the same for individual secondary prevention drugs.
This study will assess the impact of secondary prevention underutilisation on survival.
Detailed description
Using information from an England and Wales audit of acute coronary syndromes (the Myocardial Ischaemia National Audit Project (MINAP)) we aim to assess:
(i) Survival from first time MINAP-registered event to death as a function of secondary prevention medications: To what degree do the effects of medications (assumed equal, independent and additive) relate to patient survival? Is there evidence of a differential effect of discharge medications? (ii) (a) Survival from first time MINAP-registered event to death or second time MINAP-registered event as a function of secondary prevention medications: To what degree do the effects of medications (assumed equal, independent and additive) relate to competing risks? Is there evidence of a differential effect of discharge medications? (b) Survival from first time MINAP-registered event to death or second time MINAP-registered phenotyped as STEMI, NSTEMI or Unstable Angina. To what degree do the effects of medications (assumed equal, independent and additive) relate to competing risks? Is there evidence of a differential effect of discharge medications? (iii) What impact would ensuring all medication is taken have on event free survival?
This study is part of the CALIBER (Cardiovascular disease research using linked bespoke studies and electronic records) programme funded over 5 years from the NIHR and Wellcome Trust. The central theme of the CALIBER research is linkage of the Myocardial Ischaemia National Audit Project (MINAP) with primary care (GPRD) and other resources. The overarching aim of CALIBER is to better understand the aetiology and prognosis of specific coronary phenotypes across a range of causal domains, particularly where electronic records provide a contribution beyond traditional studies. CALIBER has received both Ethics approval (ref 09/H0810/16) and ECC approval (ref ECC 2-06(b)/2009 CALIBER dataset).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals with data entered into the Myocardial Ischaemia National Audit Project (MINAP) database in England and Wales.
Key inclusion criteria (1 listed)
- Individuals with Acute Coronary Syndrome who have been registered with the MINAP database.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All cause mortality
Time frame: Due to follow up an average of 3 years.
Mortality as tracked by the Office for National Statistics
1 secondary outcome
Competing risks between acute coronary syndrome phenotypes
Time frame: Due to follow up an average of 3 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2010.
- Background: PubMed 21290635National Collaborating Centre for Primary Care (UK). Post Myocardial Infarction: Secondary Prevention in Primary and Secondary Care for Patients Following a Myocardial Infarction [Internet]. London: Royal College of General Practitioners (UK); 2007 May. Available from http://www.ncbi.nlm.nih.gov/books/NBK49343/
- Background: PubMed 19619694Goodman SG, Huang W, Yan AT, Budaj A, Kennelly BM, Gore JM, Fox KA, Goldberg RJ, Anderson FA Jr; Expanded Global Registry of Acute Coronary Events (GRACE2) Investigators. The expanded Global Registry of Acute Coronary Events: baseline characteristics, management practices, and hospital outcomes of patients with acute coronary syndromes. Am Heart J. 2009 Aug;158(2):193-201.e1-5. doi: 10.1016/j.ahj.2009.06.003.
- Background: PubMed 20530127Chew DP, Anderson FA, Avezum A, Eagle KA, FitzGerald G, Gore JM, Dedrick R, Brieger D; GRACE Investigators. Six-month survival benefits associated with clinical guideline recommendations in acute coronary syndromes. Heart. 2010 Aug;96(15):1201-6. doi: 10.1136/hrt.2009.184853. Epub 2010 Jun 7.
- Background: PubMed 20353936Bramlage P, Messer C, Bitterlich N, Pohlmann C, Cuneo A, Stammwitz E, Tebbenjohanns J, Gohlke H, Senges J, Tebbe U. The effect of optimal medical therapy on 1-year mortality after acute myocardial infarction. Heart. 2010 Apr;96(8):604-9. doi: 10.1136/hrt.2009.188607. Epub 2010 Mar 29.
- CALIBER is based on linking the national myocardial infarction register to the rich longitudinal primary care recordLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Owen M Nicholas, PhD principal investigator
University College, London
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by University College, London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: Due to follow up an average of 3 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01162187, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2010; AzTrials last refreshed its copy on 6 Nov 2026.