NCT05116995

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 11, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

2 years

First QC Date

October 21, 2021

Last Update Submit

September 21, 2023

Conditions

ThrombosisMyocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • 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.

    7 days

Secondary Outcomes (2)

  • Differential effects on inflammatory markers (white cell count and CRP)

    7 days

  • Differential effects on fibrin clot lysis time

    7 days

Study Arms (2)

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.

Drug: RivaroxabanDrug: 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.

Drug: RivaroxabanDrug: Ticagrelor

Interventions

RivaroxabanDRUG

rivaroxaban 2.5 mg twice a day for 7 days

Also known as: xarelto
Rivaroxaban firstTicagrelor first
TicagrelorDRUG

Ticagrelor 60 mg twice a day for 7 days

Also known as: brilinta
Rivaroxaban firstTicagrelor first

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nova Scotia Health

Halifax, Nova Scotia, B3H 3A7, Canada

RECRUITING

MeSH Terms

Conditions

ThrombosisMyocardial Infarction

Interventions

RivaroxabanTicagrelor

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular DiseasesMyocardial IschemiaHeart DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Central Study Contacts

David M Fillmore, BSc

CONTACT

9024737417david.fillmore@nshealth.ca

Wael Sumaya, PhD

CONTACT

9024735769wael.sumaya@nshealth.ca

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
Study personnel performing bleeding time and laboratory staff will be blinded to treatment allocation.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Treatment #1 for one week then on Day 21 they enter Treatment #2 for 1 week.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Interventional Cardiologist

Study Record Dates

First Submitted

October 21, 2021

First Posted

November 11, 2021

Study Start

November 1, 2021

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

September 22, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)