Coronary Artery DiseasePhase 3SDAT-IRCNCT03789916
SAPT Versus DAPT in Incomplete Revascularization After CABG
A Phase 3 study testing Ticagrelor and acetylsalicylic acid in people with Coronary Artery Disease, run by Campus Bio-Medico University at 1 site in Italy.
Trial summary
The study aims to compare the efficacy of dual antiplatelet therapy (DAPT) over single antiplatelet therapy (SAPT) in patients with incomplete revascularization after coronary artery bypass graft surgery (CABG). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Ticagrelor and acetylsalicylic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jan 2019to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- patients undergoing CABG, ± cardiopulmonary bypass, ± any associated cardiac procedures (valve replacement,...)
- incomplete myocardial revascularization, defined by anatomic or functional criteria
- obtained informed consent
Who cannot join
- acute coronary syndrome < 12 months from surgery
- dual antiplatelet therapy at hospital admission
- planned procedure to complete myocardial revascularization (e.g. hybrid approach)
- intolerance / unable to take acetylsalicylic acid or ticagrelor
- preoperative atrial fibrillation
- impaired compliance
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- planned pregnancy
- history of gastrointestinal bleeding
- chronic kidney disease (eGFR < 30 mL/min/1.73 m2)
- chronic liver disease
- severe heart failure at hospital admission
- active malignancy
- alcohol abuse
- any clinical condition not compatible with the treatment
- Exit Criteria:
- postoperative atrial fibrillation requiring anticoagulation
- postoperative hemorrhagic events (stroke, GI bleeding)
- occurrence of contraindications to acetylsalicylic acid or ticagrelor
- surgical treatment requiring DAPT withdrawn
- patient decision
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Massimo Chello, MD contact
Italy1 site, 1 recruiting
- Recruiting
Università Campus Bio-Medico di Roma
Rome, 00128
Antonio Nenna, MD, +393337014743, a.nenna@unicampus.it
Massimo Chello, MD, m.chello@unicampus.it
About this study
Official title: Single Versus Dual Antiplatelet Therapy in Patients With Incomplete Revascularization After Coronary Artery Bypass Graft Surgery
The study aims to compare the efficacy of dual antiplatelet therapy (DAPT) over single antiplatelet therapy (SAPT) in patients with incomplete revascularization after coronary artery bypass graft surgery (CABG).
Before hospital discharge, patients will be 1:1 randomized to SAPT (acetylsalicylic acid 100 mg/die) or DAPT (acetylsalicylic acid 100 mg/die + ticagrelor 90 mg bis in die). DAPT will be continued for 12 months, and ticagrelor will be withdrawn thereafter. Primary endpoint is the evaluation of cardiac-related mortality at 5 years from hospital discharge.
- Conditions
- Coronary Artery Disease
- Being tested
- Ticagrelor, acetylsalicylic acid
- Keywords
- coronary artery bypass grafting, incomplete revascularization, coronary artery disease, dual antiplatelet therapy
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
Also called Brilique
90 mg bis in die
acetylsalicylic acidDrug
100 mg die
| Study group | Role | What they receive |
|---|---|---|
| DAPT | Experimental | "Dual antiplatelet therapy": acetylsalicylic acid 100 mg/die + ticagrelor 90 mg bis in die Receives: Drug: Ticagrelor; Drug: acetylsalicylic acid |
| SAPT | Active comparator | "Single antiplatelet therapy": acetylsalicylic acid 100 mg/die Receives: Drug: acetylsalicylic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac-related mortality
Measured: 5 years
Secondary outcomes (3)
Mortality
Overall mortality and non-cardiac-related mortality
Measured: 5 years
Major adverse cardiac and cerebrovascular events (MACCEs)
cardiac-related mortality, myocardial infarction, repeated vessel revascularization, hospitalization for heart failure, major arrhythmias, stroke
Measured: 5 years
Major adverse hemorrhagic events (MAHEs)
stroke, gastrointestinal bleeding, life-threatening bleeding
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start2 Jan 2019
- Primary completion1 Aug 2021
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Nenna, MD, Campus Bio-Medico University
- Investigators
- Massimo Chello, MD, Study chair, Università Campus Bio-Medico di Roma, Rome, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789916
- Sponsor's protocol ID
- 72.18
- Acronym
- SDAT-IRC
- Status last verified
- Jul 2022
- First submitted
- 27 Dec 2018
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Spadaccio C, Nappi F, Nenna A, Beattie G, Chello M, Sutherland FW. Is it time to change how we think about incomplete coronary revascularization? Int J Cardiol. 2016 Dec 1;224:295-298. doi: 10.1016/j.ijcard.2016.09.055. Epub 2016 Sep 18.
PubMed 27665400
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Versus Dual Antiplatelet Therapy in Patients With Incomplete Revascularization After Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT03789916
- Acronym / sponsor ID
- SDAT-IRC / 72.18
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery bypass grafting, incomplete revascularization, coronary artery disease, dual antiplatelet therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Dec 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.
The study aims to compare the efficacy of dual antiplatelet therapy (DAPT) over single antiplatelet therapy (SAPT) in patients with incomplete revascularization after coronary artery bypass graft surgery (CABG).
Before hospital discharge, patients will be 1:1 randomized to SAPT (acetylsalicylic acid 100 mg/die) or DAPT (acetylsalicylic acid 100 mg/die + ticagrelor 90 mg bis in die). DAPT will be continued for 12 months, and ticagrelor will be withdrawn thereafter. Primary endpoint is the evaluation of cardiac-related mortality at 5 years from hospital discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DAPT | Experimental | Drug: Ticagrelor, Drug: acetylsalicylic acid"Dual antiplatelet therapy": acetylsalicylic acid 100 mg/die + ticagrelor 90 mg bis in die |
| SAPT | Active comparator | Drug: acetylsalicylic acid"Single antiplatelet therapy": acetylsalicylic acid 100 mg/die |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients undergoing CABG, ± cardiopulmonary bypass, ± any associated cardiac procedures (valve replacement,...)
- incomplete myocardial revascularization, defined by anatomic or functional criteria
- obtained informed consent
Key exclusion criteria (20 listed)
- acute coronary syndrome < 12 months from surgery
- dual antiplatelet therapy at hospital admission
- planned procedure to complete myocardial revascularization (e.g. hybrid approach)
- intolerance / unable to take acetylsalicylic acid or ticagrelor
- preoperative atrial fibrillation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TicagrelorAlso: Brilique90 mg bis in die | Drug | DAPT |
| acetylsalicylic acid100 mg die | Drug | DAPT, SAPT |
Primary outcome
Cardiac-related mortality
Time frame: 5 years
3 secondary outcomes
Mortality
Time frame: 5 years
Major adverse cardiac and cerebrovascular events (MACCEs)
Time frame: 5 years
Major adverse hemorrhagic events (MAHEs)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Results publication: PubMed 27665400Spadaccio C, Nappi F, Nenna A, Beattie G, Chello M, Sutherland FW. Is it time to change how we think about incomplete coronary revascularization? Int J Cardiol. 2016 Dec 1;224:295-298. doi: 10.1016/j.ijcard.2016.09.055. Epub 2016 Sep 18.
- Individual participant dataSharing planned: Yes
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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.
Massimo Chello, MD contact
Massimo Chello, MD study chair
Università Campus Bio-Medico di Roma, Rome, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ticagrelor and acetylsalicylic acid in people with Coronary Artery Disease, run by Campus Bio-Medico University 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?
The sponsor lists 3 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 21 Jul 2022. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio Nenna, MD (+393337014743, a.nenna@unicampus.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac-related mortality (time frame: 5 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 NCT03789916, which also lists 1 linked publication.
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 21 Jul 2022.