Coronary Artery DiseaseNCT03577652
The Optimal Strategy of Switching From Clopidogrel to Ticagrelor in Patients With Complexity of Coronary Artery Disease
A study testing Ticagrelor in people with Coronary Artery Disease and Ticagrelor, run by Shenyang Northern Hospital at 1 site in China.
Trial summary
The study is to further exploring the optimal switching strategy by evaluating the pharmacodynamic responses as well as adverse events in patients with complexity of coronary artery disease managed by percutaneous coronary intervention (PCI). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease, Ticagrelor
- What is being tested?
- Ticagrelor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2017to 10 Jan 2018
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18-75
- Patients with complexity of CAD determined by coronary angiography and implanted stent successfully
- Taking clopidogrel 75mg daily over 5 days or paients never took clopidogrel previously should receive 300-600mg drugs at least 12 hours before coronary angiography
- Agreeing to participate in this trial and signed the written informed consent.
Who cannot join
- They contraindicated with ticagrelor (including: allergying to ticagrelor or its active metabolite
- Concomitanting therapy with a strong cytochrome P-450 3A inhibitor or inducer
- Previous intracranial haemorrhage or ongoing bleeds
- Moderate or severe hepatic impairment)
- Having a previous medication with ticagrelor or long term anticoagulation
- Having a history of asthma or chronic obstructive pulmonary disease (COPD) and recurrent attacked
Show all 11Show fewer
- Having an uncontrolled hypertension>180/110mmHg
- Having a hemoglobin<100g/L 9.Having a platelet counts<100×10^9/L
- Having severe renal impairment (clearance<30mL/min)
- Having a history of hepaein-induced thrombocytopenia (HIT)
- Having a pregnancy or were during lactation.
Trial locations and contacts
1 site in 1 country.
China1 site
General Hospital of Shenyang Military Region
Shenyang, Liaoning, 110016
About this study
The study is to further exploring the optimal switching strategy by evaluating the pharmacodynamic responses as well as adverse events in patients with complexity of coronary artery disease managed by percutaneous coronary intervention (PCI). All participants will be divided into three groups and recieving ticagrelor 90mg plus aspirin 100mg at 12 hours after the last dose of clopidogrel; recieving ticagrelor 90mg plus aspirin 100mg at 24 hours after the last dose of clopidogrel; recieving ticagrelor 180mg plus aspirin 100mg at 24 hours after the last dose of clopidogrel.
- Conditions
- Coronary Artery Disease, Ticagrelor
- Being tested
- Ticagrelor
- Keywords
- Ticagrelor, Clopidogrel, Switching strategy
- 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
Ticagrelor, 90mg, 90mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor, 90mg, 12h | Experimental | Not described Receives: Drug: Ticagrelor |
| Ticagrelor, 90mg, 24h | Experimental | Not described Receives: Drug: Ticagrelor |
| Ticagrelor, 180mg, 24h | Experimental | Not described Receives: Drug: Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet function assessments
The primary endpoint was the comparations between the three projects for the value changes of maximal platelet aggregation (MPA) measured by Light Transmittance Aggregometry (LTA) at 2 hours after switching strategies.
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start10 Jul 2017
- Primary completion10 Jan 2018
- Study completion10 Jan 2018
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenyang Northern Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Yaling, MD, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577652
- Sponsor's protocol ID
- 20180621
- Status last verified
- Jun 2018
- First submitted
- 20 Jun 2018
- Last updated
- 5 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yao Y, Wang P, Wang XZ, Zhao X, Zhao W, Zhou TN, Zhang L. Optimal strategy of switching from clopidogrel to ticagrelor in Chinese acute coronary syndrome patients with complicated coronary artery disease: the switching from clopidogrel to ticagrelor (SHIFT-CACS) study. Chin Med J (Engl). 2019 Oct 5;132(19):2292-2299. doi: 10.1097/CM9.0000000000000444.
PubMed 31567375
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimal Strategy of Switching From Clopidogrel to Ticagrelor in Patients With Complexity of Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT03577652
- Acronym / sponsor ID
- 20180621
- Conditions
- Coronary Artery Disease, Ticagrelor
- Keywords
- Ticagrelor, Clopidogrel, Switching strategy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Shenyang Northern HospitalUniversity, hospital or other
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 10 Jan 2018 (actual)
- Study completion
- 10 Jan 2018 (actual)
- First posted
- 5 Jul 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 is to further exploring the optimal switching strategy by evaluating the pharmacodynamic responses as well as adverse events in patients with complexity of coronary artery disease managed by percutaneous coronary intervention (PCI). All participants will be divided into three groups and recieving ticagrelor 90mg plus aspirin 100mg at 12 hours after the last dose of clopidogrel; recieving ticagrelor 90mg plus aspirin 100mg at 24 hours after the last dose of clopidogrel; recieving ticagrelor 180mg plus aspirin 100mg at 24 hours after the last dose of clopidogrel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor, 90mg, 12h | Experimental | Drug: Ticagrelor |
| Ticagrelor, 90mg, 24h | Experimental | Drug: Ticagrelor |
| Ticagrelor, 180mg, 24h | Experimental | Drug: Ticagrelor |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18-75
- Patients with complexity of CAD determined by coronary angiography and implanted stent successfully
- Taking clopidogrel 75mg daily over 5 days or paients never took clopidogrel previously should receive 300-600mg drugs at least 12 hours before coronary angiography
- Agreeing to participate in this trial and signed the written informed consent.
Key exclusion criteria (11 listed)
- They contraindicated with ticagrelor (including: allergying to ticagrelor or its active metabolite
- Concomitanting therapy with a strong cytochrome P-450 3A inhibitor or inducer
- Previous intracranial haemorrhage or ongoing bleeds
- Moderate or severe hepatic impairment)
- Having a previous medication with ticagrelor or long term anticoagulation
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 |
|---|---|---|
| TicagrelorTicagrelor, 90mg, 90mg twice daily | Drug | Ticagrelor, 180mg, 24h, Ticagrelor, 90mg, 12h, Ticagrelor, 90mg, 24h |
Primary outcome
Platelet function assessments
Time frame: 7 Days
The primary endpoint was the comparations between the three projects for the value changes of maximal platelet aggregation (MPA) measured by Light Transmittance Aggregometry (LTA) at 2 hours after switching strategies.
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 5 Jul 2018.
- Derived from this study: PubMed 31567375Yao Y, Wang P, Wang XZ, Zhao X, Zhao W, Zhou TN, Zhang L. Optimal strategy of switching from clopidogrel to ticagrelor in Chinese acute coronary syndrome patients with complicated coronary artery disease: the switching from clopidogrel to ticagrelor (SHIFT-CACS) study. Chin Med J (Engl). 2019 Oct 5;132(19):2292-2299. doi: 10.1097/CM9.0000000000000444.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ticagrelor in people with Coronary Artery Disease and Ticagrelor, run by Shenyang Northern Hospital at 1 site in China.
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 4 inclusion and 11 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 5 Jul 2018. 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 China. 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?
Platelet function assessments (time frame: 7 Days). 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 NCT03577652, 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 5 Jul 2018.