Acute Coronary SyndromeCHANGE DAPTNCT03197298
Change of Dual Antiplatelet Therapy in Patients With Acute Coronary Syndrome
An observational study of Acute Coronary Syndrome and Percutaneous Coronary Intervention, run by Thorax Centrum Twente at 1 site in Netherlands.
Trial summary
Acute coronary syndrome (ACS) guidelines have been changed, favoring dual antiplatelet therapy (DAPT) with the more potent P2Y12 inhibitor ticagrelor over clopidogrel (besides aspirin). This change is based on studies that showed benefits of ticagrelor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Percutaneous Coronary Intervention, Drug-Eluting Stents
- What is being tested?
- Clopidogrel and Ticagrelor
- How many people
- 2,062 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Dec 2012to 25 Jul 2016
- 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
- Adult, Older adult
Study population: Patients admitted to the primary cardiac care clinic of the Thoraxcentrum Twente
Who may be able to join
- Presentation with acute coronary syndrome (ACS)
- Treated with newer-generation drug-eluting stent (DES) in coronary artery or bypass graft lesion
Who cannot join
- Known pregnancy
- Life expectancy less than one year
- Planned elective surgery requiring interruption of DAPT in the first 6 months
- Known intolerance to components of the DES available
- Indication for oral anticoagulation at baseline
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clopidogrel or Ticagrelor in Acute Coronary Syndrome Patients Treated With Newer-Generation Drug-Eluting Stents: CHANGE DAPT
Acute coronary syndrome (ACS) guidelines have been changed, favoring dual antiplatelet therapy (DAPT) with the more potent P2Y12 inhibitor ticagrelor over clopidogrel (besides aspirin). This change is based on studies that showed benefits of ticagrelor. However, study participants were only partly treated by percutaneous coronary intervention (PCI). In patients who were treated by PCI, this was generally performed using of bare metal or first-generation drug-eluting stents (DES).
CHANGE DAPT is an investigator-initiated, prospective, single centre registry, in which we evaluate the impact of the guideline suggested change in the primary DAPT regimen (from clopidogrel to ticagrelor) on 1-year clinical outcome in ACS patients treated by PCI with newer-generation DES in the Thoraxcentrum Twente.
- Being tested
- Clopidogrel, Ticagrelor
- Keywords
- Acute Coronary Syndrome, Percutaneous Coronary Intervention, Drug-Eluting Stents, Platelet Aggregation Inhibitors, Ticagrelor, clopidogrel, Purinergic P2Y Receptor Antagonists
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
Also called Plavix
TicagrelorDrug
Also called Brilinta, Brilique
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel Period | ACS patients treated by PCI with newer-generation DES before the guideline suggested change in primary DAPT-regimen Receives: Drug: Clopidogrel | |
| Ticagrelor Period | ACS patients treated by PCI with newer-generation DES after the guideline suggested change in primary DAPT-regimen Receives: Drug: Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net adverse clinical and cerebral events (NACCE)
A composite of all-cause death, any myocardial infarction, stroke, or major bleeding.
Measured: 1 year
Secondary outcomes (6)
All-cause death
All-cause mortality
Measured: 1 year
Any myocardial infarction
According to the Academic Research Consortium (ARC) definition
Measured: 1 year
Stroke
Focal loss of neurologic function caused by an ischemic or hemorrhagic event with residual symptoms lasting at least 24 hours or leading to death
Measured: 1 year
Major Bleeding
Defined by Thrombolysis in Myocardial Infarction (TIMI) major bleeding or TIMI in the setting of coronary artery bypass grafting, and/or any Bleeding Academic Research Consortium (BARC) class 3 or 5.
Measured: 1 year
Any clinically indicated revascularization
Revascularization by PCI or CABG
Measured: 1 year
Stent thrombosis
According to the Academic Research Consortium (ARC) definition
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start21 Dec 2012
- Primary completion25 Jul 2016
- Study completion25 Jul 2016
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 Acute Coronary SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,062 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Thorax Centrum Twente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clemens von Birgelen, MD,PhD,Prof, Study director, Thoraxcentrum TwenteK. Gert van Houwelingen, MD, Principal investigator, Thoraxcentrum Twente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03197298
- Sponsor's protocol ID
- K14-22
- Acronym
- CHANGE DAPT
- Status last verified
- Jun 2017
- First submitted
- 23 May 2017
- Last updated
- 23 Jun 2017
- Results posted
- No
Publications
Zocca P, van der Heijden LC, Kok MM, Lowik MM, Hartmann M, Stoel MG, Louwerenburg JW, de Man FHAF, Linssen GCM, Knottnerus IL, Doggen CJM, van Houwelingen KG, von Birgelen C. Clopidogrel or ticagrelor in acute coronary syndrome patients treated with newer-generation drug-eluting stents: CHANGE DAPT. EuroIntervention. 2017 Nov 20;13(10):1168-1176. doi: 10.4244/EIJ-D-17-00634.
PubMed 29151439
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clopidogrel or Ticagrelor in Acute Coronary Syndrome Patients Treated With Newer-Generation Drug-Eluting Stents: CHANGE DAPT
- ClinicalTrials.gov ID
- NCT03197298
- Acronym / sponsor ID
- CHANGE DAPT / K14-22
- Keywords
- Acute Coronary Syndrome, Percutaneous Coronary Intervention, Drug-Eluting Stents, Platelet Aggregation Inhibitors, Ticagrelor, clopidogrel, Purinergic P2Y Receptor Antagonists
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,062 participants (actual)
- Lead sponsor
- Thorax Centrum TwenteUniversity, hospital or other
- Study start
- 21 Dec 2012 (actual)
- Primary completion
- 25 Jul 2016 (actual)
- Study completion
- 25 Jul 2016 (actual)
- First posted
- 23 Jun 2017 (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.
Acute coronary syndrome (ACS) guidelines have been changed, favoring dual antiplatelet therapy (DAPT) with the more potent P2Y12 inhibitor ticagrelor over clopidogrel (besides aspirin). This change is based on studies that showed benefits of ticagrelor. However, study participants were only partly treated by percutaneous coronary intervention (PCI). In patients who were treated by PCI, this was generally performed using of bare metal or first-generation drug-eluting stents (DES).
CHANGE DAPT is an investigator-initiated, prospective, single centre registry, in which we evaluate the impact of the guideline suggested change in the primary DAPT regimen (from clopidogrel to ticagrelor) on 1-year clinical outcome in ACS patients treated by PCI with newer-generation DES in the Thoraxcentrum Twente.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel Period | – | Drug: ClopidogrelACS patients treated by PCI with newer-generation DES before the guideline suggested change in primary DAPT-regimen |
| Ticagrelor Period | – | Drug: TicagrelorACS patients treated by PCI with newer-generation DES after the guideline suggested change in primary DAPT-regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the primary cardiac care clinic of the Thoraxcentrum Twente
Key inclusion criteria (2 listed)
- Presentation with acute coronary syndrome (ACS)
- Treated with newer-generation drug-eluting stent (DES) in coronary artery or bypass graft lesion
Key exclusion criteria (5 listed)
- Known pregnancy
- Life expectancy less than one year
- Planned elective surgery requiring interruption of DAPT in the first 6 months
- Known intolerance to components of the DES available
- Indication for oral anticoagulation at baseline
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 |
|---|---|---|
| ClopidogrelAlso: Plavix | Drug | Clopidogrel Period |
| TicagrelorAlso: Brilinta, Brilique | Drug | Ticagrelor Period |
Primary outcome
Net adverse clinical and cerebral events (NACCE)
Time frame: 1 year
A composite of all-cause death, any myocardial infarction, stroke, or major bleeding.
6 secondary outcomes
All-cause death
Time frame: 1 year
Any myocardial infarction
Time frame: 1 year
Stroke
Time frame: 1 year
Major Bleeding
Time frame: 1 year
Any clinically indicated revascularization
Time frame: 1 year
Stent thrombosis
Time frame: 1 year
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 23 Jun 2017.
- Derived from this study: PubMed 29151439Zocca P, van der Heijden LC, Kok MM, Lowik MM, Hartmann M, Stoel MG, Louwerenburg JW, de Man FHAF, Linssen GCM, Knottnerus IL, Doggen CJM, van Houwelingen KG, von Birgelen C. Clopidogrel or ticagrelor in acute coronary syndrome patients treated with newer-generation drug-eluting stents: CHANGE DAPT. EuroIntervention. 2017 Nov 20;13(10):1168-1176. doi: 10.4244/EIJ-D-17-00634.
Related trials for Acute Coronary Syndrome
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
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.
Clemens von Birgelen, MD,PhD,Prof study director
Thoraxcentrum Twente
K. Gert van Houwelingen, MD principal investigator
Thoraxcentrum Twente
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 Acute Coronary Syndrome and Percutaneous Coronary Intervention, run by Thorax Centrum Twente at 1 site in Netherlands.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 23 Jun 2017. 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 Netherlands. 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?
Net adverse clinical and cerebral events (NACCE) (time frame: 1 year). 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 NCT03197298, 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 23 Jun 2017.