Status: Ongoing
First registered on:
15/07/2019
Last updated on:
25/03/2021
1. Study identification
EU PAS Register NumberEUPAS29177
Official titleDual antiplatelet therapy for prolonged secondary prevention of acute coronary events
Study title acronymDEEPSPACE
Study typeOther: Historical cohort study using the SNDS, the French nationwide claims database
Brief description of the studyDual antiplatelet therapy (DAPT) is recommended for one year after an acute coronary syndrome (ACS), but the benefits and risks of longer duration of DAPT remain disputed. The PEGASUS-TIMI 54 clinical trial found a beneficial effect of prolonged DAPT with ticagrelor in chronic stable high-risk patients, but its generalizability is uncertain. The latest recommendations from the European Society of Cardiology remain relatively conservative considering that extension of DAPT beyond 1 year (up to 3 years) in the form of aspirin plus ticagrelor 60 mg bid may be considered in patients who have tolerated DAPT without a bleeding complication and having an additional risk factor for ischaemic events. In this context, the DEEPSPACE study purpose is to compare in real-life event rate (i.e. composite criterion of ACS, stroke, major bleeding, or death for main outcome, and individual events for secondary outcomes) on DAPT with any of the three P2Y12 antagonists (clopidogrel, ticagrelor, or prasugrel) plus aspirin to aspirin alone, over 3 years beyond one year after ACS, using the French nationwide claims database (SNDS). The cohort will include all patients hospitalised for an initial ACS (trigger event) between 2013 and 2014, and having one year of event-free DAPT after this initial ACS. The index date will be the one-year anniversary date for the ACS discharge, and each patient will be followed 3 years or until death and will have 2-year history prior the index date in the database. It is expected 50 000 patients included in the study after one-year event-free on DAPT with an event occurrence estimate to 5 200 composite events and 1 000 deaths. The outcomes will be described during the exposure period according to treatment groups in terms of crude incidence rate (Normal approximation), cumulative incidence rate (Kaplan-Meier estimator or Cumulative Incidence Function), and risk factors of outcomes (Cox proportional hazards models or Fine and Grey models).
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Department/Research grouppharmacoepidemiology
Organisation/affiliationUniversity of Bordeaux
Details of (Primary) lead investigator
Title Professor
Last name Moore
First name Nicholas
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)
Countries in which this study is being conducted
National study
France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed21/06/2019
Start date of data collection31/12/201926/02/2020
Start date of data analysis03/05/2021
Date of interim report, if expected
Date of final study report30/09/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyFrench Ministry of Health (PHRCN-18-0745)100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Moore
First name Nicholas
Address line 1University of Bordeaux
Address line 2146 Rue Léo Saignat
Address line 3Bâtiment du Tondu - Case 41
CityBordeaux
Postcode33076
CountryFrance
Phone number (incl. country code)33557574675
Alternative phone number
Fax number (incl. country code)33557574740
Public Enquiries
Title Professor
Last name Moore
First name Nicholas
Address line 1University of Bordeaux
Address line 2146 Rue Léo Saignat
Address line 3Bâtiment du Tondu - Case 41
CityBordeaux
Postcode33076
CountryFrance
Phone number (incl. country code)33557574675
Alternative phone number
Fax number (incl. country code)33557574740
6. Study drug(s) information
Substance class (ATC Code)B01AC04 (clopidogrel)
Substance class (ATC Code)B01AC24 (ticagrelor)
Substance class (ATC Code)B01AC22 (prasugrel)
Substance class (ATC Code)B01AC06 (acetylsalicylic acid)
7. Medical conditions to be studied
Medical condition(s)Yes
Acute coronary syndrome
8. Population under study
Age
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects50000
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources not registered with ENCePP
SNDS NATIONAL CLAIMS DATABASE, France
Sources of data
Administrative database, e.g. claims database
11. Scope of the study
What is the scope of the study?
Disease epidemiology
Risk assessment
Drug utilisation study
Primary scope : Risk assessment
12. Main objective(s)
What is the main objective of the study?
The main objective is to compare event rates on DAPT with any of the three P2Y12 antagonists plus aspirin to single antiplatelet therapy (SAPT) with aspirin alone, over 3 years beyond one year after initial coronary event.
Are there primary outcomes?Yes
Composite of all-cause death, ACS, stroke, or major bleeding.
Are there secondary outcomes?Yes
All-cause death, ACS (STEMI, NSTEMI and unstable angina), stroke (ischemic or undefined stroke), major bleeding (intracranial bleeding, upper GI bleeding, other major bleeding).
13. Study design
What is the design of the study?
Cohort study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
The index date is the one-year anniversary date for the discharge of each subject for initial ACS identified from 01/01/2013 to 31/12/2014. The study follow-up period will start on the study index date occurring from 01/01/2014 to 31/12/2015 and will end three years later, or until date of death.
15. Data analysis plan
Please provide a brief summary of the analysis method
The following analyses will be performed:
- Description of patients at baseline and during the 3 years of follow-up, overall and by treatment group with standardized differences before and after adjustment for / matching on hdPS;
- A hdPS will be estimated for each comparison (clopidogrel, ticagrelor or prasugrel + aspirin vs aspirin alone) using a multivariable logistic regression model with multiple data dimensions from patients and healthcare reimbursements before index date;
- Estimation of outcome incidences during the drug exposure period (all and matched patients) in each treatment group using Kaplan-Meier estimator for death and composite criterion, or cumulative incidence function estimate for other single outcomes in order to take into account death as competing risk;
- Comparison of outcome rates between treatment groups using Cox proportional hazard models for death and composite criterion, and Fine and Gray competing risks models for non-fatal outcomes.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Not submitted
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
