Dual Anti-platelet TherapyRE-SCORENCT03526614
REpetitive Assessement of SCOREs in Patients on Dual Antiplatelet Therapy
An observational study of Dual Anti-platelet Therapy, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
Patients treated with percutaneous coronary intervention (PCI) require dual antiplatelet therapy (DAPT). Preliminary assessment of the PRECISE-DAPT score is mandatory in order to assess the risk of bleeding while on DAPT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dual Anti-platelet Therapy
- How many people
- 480 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2017to 31 Dec 2019
- How long will I take part?
- 1 Year
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with coronary artery disease and indication to PCI
Inclusion Criteria: All patients undergoing percutaneous coronary intervention and treated with dual antiplatelet therapy for at least 3 months
Exclusion Criteria: Contraindications to dual antiplatelet therapy lasting more than 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: REpetitive Assessement of Thromboembolic and Bleeding SCOREs in Patients Treated With Dual Antiplatelet Therapy
Patients treated with percutaneous coronary intervention (PCI) require dual antiplatelet therapy (DAPT). Preliminary assessment of the PRECISE-DAPT score is mandatory in order to assess the risk of bleeding while on DAPT. The score takes into consideration age, creatinine clearance, haemoglobin, white-blood-cell count and previous spontaneous bleeding. One should consider, however, that some of the variables included in the PRECISE-DAPT score might change with time. As a consequence, the PRECISE-DAPT score should not be considered a static score as it might vary after the initial computation. It remains unknown, however, if the delta PRECISE-SCORE, reflecting the change in score between baseline and follow-up, might predict more reliably the long-term bleeding risk of PCI patients.
Read the detailed description
The RE-SCORE registry is a multicenter study aimed at comparing the predictive value of the PRECISE-DAPT score assessed at time of discharge vs. the Delta PRECISE-DAPT score, as assessed every 3 months in PCI patients receiving DAPT.
The primary end-point of the study is the occurrence of bleeding, as defined according to the criteria of the Bleeding Academic Research Consortium (BARC), either in the whole study population or in men vs women.
- Conditions
- Dual Anti-platelet Therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding in the overall population
Bleeding episodes
Measured: Up to 12 months
Bleeding in men and women
Bleeding episodes
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start1 Jun 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dual Anti-platelet TherapyStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe 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
- Prospective
- Enrolment
- 480 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Pelliccia, University of Roma La Sapienza
- Investigators
- Francesco Pelliccia, Study chair, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526614
- Sponsor's protocol ID
- 2018/D/401
- Acronym
- RE-SCORE
- Status last verified
- Apr 2021
- First submitted
- 3 May 2018
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pelliccia F, Gragnano F, Pasceri V, Marazzi G, Cacciotti L, Placanica A, Niccoli G, Palmerini T, Speciale G, Granatelli A, Calabro P. Gender-related differences in changes of estimated bleeding risk in patients on dual antiplatelet therapy: the RE-SCORE multicenter prospective registry. Platelets. 2022 Nov 17;33(8):1228-1236. doi: 10.1080/09537104.2022.2102602. Epub 2022 Jul 25.
PubMed 35875853Pelliccia F, Pasceri V, Marazzi G, Cacciotti L, Placanica A, Gragnano F, Niccoli G, Palmerini T, Tanzilli G, Speciale G, Granatelli A, Calabro P, Crea F, Gaudio C. Predictive ability of longitudinal changes in PRECISE-DAPT score in patients on dual antiplatelet therapy: The RE-SCORE multicentre prospective registry. Eur J Prev Cardiol. 2021 Oct 13;28(12):e36-e38. doi: 10.1177/2047487320937846. Epub 2020 Jul 5. No abstract available.
PubMed 34647586
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REpetitive Assessement of Thromboembolic and Bleeding SCOREs in Patients Treated With Dual Antiplatelet Therapy
- ClinicalTrials.gov ID
- NCT03526614
- Acronym / sponsor ID
- RE-SCORE / 2018/D/401
- Conditions
- Dual Anti-platelet Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 16 May 2018 (actual)
- 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.
Patients treated with percutaneous coronary intervention (PCI) require dual antiplatelet therapy (DAPT). Preliminary assessment of the PRECISE-DAPT score is mandatory in order to assess the risk of bleeding while on DAPT. The score takes into consideration age, creatinine clearance, haemoglobin, white-blood-cell count and previous spontaneous bleeding. One should consider, however, that some of the variables included in the PRECISE-DAPT score might change with time. As a consequence, the PRECISE-DAPT score should not be considered a static score as it might vary after the initial computation. It remains unknown, however, if the delta PRECISE-SCORE, reflecting the change in score between baseline and follow-up, might predict more reliably the long-term bleeding risk of PCI patients.
Detailed description
The RE-SCORE registry is a multicenter study aimed at comparing the predictive value of the PRECISE-DAPT score assessed at time of discharge vs. the Delta PRECISE-DAPT score, as assessed every 3 months in PCI patients receiving DAPT.
The primary end-point of the study is the occurrence of bleeding, as defined according to the criteria of the Bleeding Academic Research Consortium (BARC), either in the whole study population or in men vs women.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary artery disease and indication to PCI
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
Bleeding in the overall population
Time frame: Up to 12 months
Bleeding episodes
Bleeding in men and women
Time frame: Up to 12 months
Bleeding episodes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Derived from this study: PubMed 35875853Pelliccia F, Gragnano F, Pasceri V, Marazzi G, Cacciotti L, Placanica A, Niccoli G, Palmerini T, Speciale G, Granatelli A, Calabro P. Gender-related differences in changes of estimated bleeding risk in patients on dual antiplatelet therapy: the RE-SCORE multicenter prospective registry. Platelets. 2022 Nov 17;33(8):1228-1236. doi: 10.1080/09537104.2022.2102602. Epub 2022 Jul 25.
- Derived from this study: PubMed 34647586Pelliccia F, Pasceri V, Marazzi G, Cacciotti L, Placanica A, Gragnano F, Niccoli G, Palmerini T, Tanzilli G, Speciale G, Granatelli A, Calabro P, Crea F, Gaudio C. Predictive ability of longitudinal changes in PRECISE-DAPT score in patients on dual antiplatelet therapy: The RE-SCORE multicentre prospective registry. Eur J Prev Cardiol. 2021 Oct 13;28(12):e36-e38. doi: 10.1177/2047487320937846. Epub 2020 Jul 5. No abstract available.
- Individual participant dataSharing planned: Undecided
Related trials for Dual Anti-platelet Therapy
Not yet recruitingPhase 4
Aspirin-Free Strategy After 3-6 Month Dual Antiplatelet Therapy in Acute Coronary Syndrome
Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI), Dual Anti-platelet Therapy
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.
Francesco Pelliccia study chair
University of Roma La Sapienza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dual Anti-platelet Therapy, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bleeding in the overall population (time frame: Up to 12 months). The study lists 2 primary outcomes in all. 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 NCT03526614, which also lists 2 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 19 Apr 2021; AzTrials last refreshed its copy on 8 Nov 2026.