ThrombosisPhase 4DEFINE CCSNCT05116995
Differential EFfects of Dual antIplatelet and Dual aNtithrombotic thErapy on Hemostasis in Chronic Coronary Syndrome Patients
A Phase 4 study testing Rivaroxaban and Ticagrelor in people with Thrombosis and Myocardial Infarction, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
The investigators will be comparing the effects of two different drug treatment strategies, in patients with history of a heart attack, on different markers of bleeding and clotting risk. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Thrombosis, Myocardial Infarction
- What is being tested?
- Rivaroxaban and Ticagrelor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2021to 1 Nov 2023
- Phase
- Phase 4
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic coronary syndrome (at least 1 year after having a myocardial infarction) on aspirin monotherapy will be eligible for this study. They have to have at least one of these additional risk factors:
- Diffuse coronary artery disease.
- Peripheral vascular disease
- Diabetes
- Chronic kidney disease (eGFR<60 ml/unit/1.73 m2)
Who cannot join
- Allergy to either rivaroxaban or ticagrelor
- Requirement for anticoagulation or P2Y12 inhibitor therapy
- Anemia (hemoglobin < 10 g/dL)
- Severe renal impairment (eGFR < 30 ml/unit/1.73 m2)
- Bleeding disorders
- Significant liver impairment resulting in deranged clotting parameters
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- Any history of intracranial hemorrhage
- Stroke within 6 months
- History of gastrointestinal bleed within 6 months
- Major surgery within 1 month
- Patients with inflammatory conditions
- Concomitant treatment with immunosuppressive therapy, inhibitors or inducers of P glycoprotein or CYP3A4 enzymes (eg. azole antifungals, ritonavir, erythromycin, clarithromycin, rifampicin)
- Concomitant treatment with antidepressants (selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors)
- Pregnancy
- Inability to give written consent
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Nova Scotia Health
Halifax, Nova Scotia, B3H 3A7
David M Fillmore, BSc, 902-473-7417
About this study
Official title: Differential EFfects of Dual antIplatelet and Dual aNtithrombotic thErapy on Hemostasis in Chronic Coronary Syndrome Patients: Define CCS Study, a Prospective Randomized Crossover Clinical Trial.
The investigators will be comparing the effects of two different drug treatment strategies, in patients with history of a heart attack, on different markers of bleeding and clotting risk. Both treatment strategies are already approved for the indication of improving outcomes in high-risk patients with history of heart attack.
Read the detailed description
The investigators will enroll patients with coronary disease >1 year after an acute coronary syndrome. Subjects will be randomized to one of two treatment plans. One plan the participant will take ticagrelor for one week, then take two weeks off with no drug (washout period), then one week of rivaroxaban. The other plan will be reverse order where the participant will take rivaroxaban for one week, then two weeks off(washout period), then one week of ticagrelor. Study drugs will be provided to participants at the start of each treatment period. Bleeding time will be determined and blood samples will be taken at four timepoints (baseline, post first drug, pre second drug, and post second drug) to measure complete blood count, CRP, and fibrin clot assessment. These are surrogate markers for safety (bleeding) and efficacy (increased thrombotic risk)
- Conditions
- Thrombosis, Myocardial Infarction
- Being tested
- Rivaroxaban, Ticagrelor
- Medical subject headings
- Thrombosis, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
Also called xarelto
rivaroxaban 2.5 mg twice a day for 7 days
TicagrelorDrug
Also called brilinta
Ticagrelor 60 mg twice a day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban first | Active comparator | Patients will be treated with rivaroxaban 2.5 mg twice a day for one week then on Day 21, will be treated with ticagrelor 60 mg twice a day for one week. Receives: Drug: Rivaroxaban; Drug: Ticagrelor |
| Ticagrelor first | Active comparator | Patients will be treated with ticagrelor 60 mg twice a day for one week then on Day 21, will be treated with rivaroxaban 2.5 mg twice a day for one week. Receives: Drug: Rivaroxaban; Drug: Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding time
The primary objective is to determine the differential effect of rivaroxaban and ticagrelor on bleeding time as a surrogate marker for bleeding tendency.
Measured: 7 days
Secondary outcomes (2)
Differential effects on inflammatory markers (white cell count and CRP)
These will be measured from blood draws
Measured: 7 days
Differential effects on fibrin clot lysis time
This will be measured from blood draws
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 posted11 Nov 2021
- Study start1 Nov 2021
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Treatment #1 for one week then on Day 21 they enter Treatment #2 for 1 week.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wael Sumaya, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116995
- Sponsor's protocol ID
- SUM001
- Acronym
- DEFINE CCS
- Status last verified
- Sep 2023
- First submitted
- 21 Oct 2021
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential EFfects of Dual antIplatelet and Dual aNtithrombotic thErapy on Hemostasis in Chronic Coronary Syndrome Patients: Define CCS Study, a Prospective Randomized Crossover Clinical Trial.
- ClinicalTrials.gov ID
- NCT05116995
- Acronym / sponsor ID
- DEFINE CCS / SUM001
- Conditions
- Thrombosis, Myocardial Infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 11 Nov 2021 (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 investigators will be comparing the effects of two different drug treatment strategies, in patients with history of a heart attack, on different markers of bleeding and clotting risk. Both treatment strategies are already approved for the indication of improving outcomes in high-risk patients with history of heart attack.
Detailed description
The investigators will enroll patients with coronary disease >1 year after an acute coronary syndrome. Subjects will be randomized to one of two treatment plans. One plan the participant will take ticagrelor for one week, then take two weeks off with no drug (washout period), then one week of rivaroxaban. The other plan will be reverse order where the participant will take rivaroxaban for one week, then two weeks off(washout period), then one week of ticagrelor. Study drugs will be provided to participants at the start of each treatment period. Bleeding time will be determined and blood samples will be taken at four timepoints (baseline, post first drug, pre second drug, and post second drug) to measure complete blood count, CRP, and fibrin clot assessment. These are surrogate markers for safety (bleeding) and efficacy (increased thrombotic risk)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Treatment #1 for one week then on Day 21 they enter Treatment #2 for 1 week.
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban first | Active comparator | Drug: Rivaroxaban, Drug: TicagrelorPatients will be treated with rivaroxaban 2.5 mg twice a day for one week then on Day 21, will be treated with ticagrelor 60 mg twice a day for one week. |
| Ticagrelor first | Active comparator | Drug: Rivaroxaban, Drug: TicagrelorPatients will be treated with ticagrelor 60 mg twice a day for one week then on Day 21, will be treated with rivaroxaban 2.5 mg twice a day for one week. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with chronic coronary syndrome (at least 1 year after having a myocardial infarction) on aspirin monotherapy will be eligible for this study. They have to have at least one of these additional risk factors:
Key exclusion criteria (15 listed)
- Allergy to either rivaroxaban or ticagrelor
- Requirement for anticoagulation or P2Y12 inhibitor therapy
- Anemia (hemoglobin < 10 g/dL)
- Severe renal impairment (eGFR < 30 ml/unit/1.73 m2)
- Bleeding disorders
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 |
|---|---|---|
| RivaroxabanAlso: xareltorivaroxaban 2.5 mg twice a day for 7 days | Drug | Rivaroxaban first, Ticagrelor first |
| TicagrelorAlso: brilintaTicagrelor 60 mg twice a day for 7 days | Drug | Rivaroxaban first, Ticagrelor first |
Primary outcome
Bleeding time
Time frame: 7 days
The primary objective is to determine the differential effect of rivaroxaban and ticagrelor on bleeding time as a surrogate marker for bleeding tendency.
2 secondary outcomes
Differential effects on inflammatory markers (white cell count and CRP)
Time frame: 7 days
Differential effects on fibrin clot lysis time
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rivaroxaban and Ticagrelor in people with Thrombosis and Myocardial Infarction, run by Nova Scotia Health Authority at 1 site in Canada.
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 5 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 22 Sep 2023. 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 Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David M Fillmore, BSc (9024737417, david.fillmore@nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding time (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2023.