Recruiting

Dual Antiplatelet & Dual Antithrombotic

Sponsor:

Nova Scotia Health Authority

Code:

NCT05116995

Conditions

Thrombosis

Myocardial Infarction

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Rivaroxaban

Ticagrelor

Study Details

Brief 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. Both treatment strategies are already approved for the indication of improving outcomes in high-risk patients with history of heart attack.

Conditions

Thrombosis

Myocardial Infarction

Study ID

NCT05116995

Start date

Nov 1, 2021

Status verified date

Sep, 2023

Completion date

Nov 1, 2023

Anticipated

Primary completion date

Nov 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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:

1. Diffuse coronary artery disease.
2. Peripheral vascular disease
3. Diabetes
4. Chronic kidney disease (eGFR<60 ml/unit/1.73 m2)

Exclusion Criteria:

  • 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
  • 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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Rivaroxaban first

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.

active comparator: Ticagrelor first

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.

Interventions

Rivaroxaban

rivaroxaban 2.5 mg twice a day for 7 days

Ticagrelor

Ticagrelor 60 mg twice a day for 7 days

Primary outcome measure

  • Bleeding time [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

David M Fillmore, BSc

9024737417david.fillmore@nshealth.ca

Wael Sumaya, PhD

9024735769wael.sumaya@nshealth.ca

Locations

Nova Scotia Health

Recruiting

Halifax, Nova Scotia, Canada, B3H 3A7

Contacts

David M Fillmore, BSc

902-473-7417

More Information

Sponsor

Nova Scotia Health Authority

Last update posted

Sep 22, 2023

Last verified

Sep, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nova Scotia Health Authority on 2023-09-22.