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Atrial FibrillationPhase 3CAPITAL PCI AFNCT03331484

The Safety and Efficacy Of Rivaroxaban and Ticagrelor for Patients With Atrial Fibrillation After Percutaneous Coronary Intervention

A Phase 3 study testing Ticagrelor and Rivaroxaban in people with Atrial Fibrillation and Acute Coronary Syndrome, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Currently, there is minimal data on the combination of rivaroxaban and ticagrelor in patients with atrial fibrillation (AF) managed with percutaneous coronary intervention (PCI). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation, Acute Coronary Syndrome
What is being tested?
Ticagrelor and Rivaroxaban
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteCanada
Study dates
1 Nov 2018to 6 Jul 2023
Phase
Phase 3
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient has undergone a PCI with stent placement, plus
  • Documented non-valvular atrial fibrillation (AF)* within 1 year before screening, OR >1 year before screening if patient had been receiving oral anticoagulation (OAC)therapy for the atrial fibrillation for 3 months immediately before the index PCI.
  • AF is defined by its presence on an electrocardiogram (ECG), Holter monitor, or any device that provides a rhythm strip documenting paroxysmal, persistent or, permanent atrial fibrillation.
  • Atrial flutter can be included as "AF equivalent". The stroke risk in patients with atrial flutter is not much different from that in AF. Furthermore, many patients diagnosed with atrial flutter subsequently develop AF. Hence, current guidelines recommend that OAC should be used in patients with atrial flutter similar to that in patients with AF.
  • Non-valvular AF is defined as the absence of moderate to severe mitral stenosis or the presence of a mechanical valve as per 2016 ESC guidelines.

Who cannot join

  • Age <18 years old
  • Any condition that contraindicates anticoagulant therapy or would confer an unacceptable risk of bleeding, such as, but not limited to:
  • active internal bleeding, ii. bleeding at a non-compressible site, iii. bleeding diathesis within 30 days of PCI, iv. baseline platelet count <90,000/μL, v. history of intracranial hemorrhage, vi. clinically significant gastrointestinal bleeding within 12 months of PCI, vii. baseline INR > 1.5 in patients not prescribed VKA, suggesting underlying coagulation disorder.
  • History of stroke
  • Cardiogenic shock at the time of screening
  • Ventricular arrhythmias refractory to treatment at the time of screening
Show all 20Show fewer
  • Calculated CrCl <30 mL/min at the time of screening
  • Known significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis), or liver function test (LFT) abnormalities at screening: alanine transaminase (ALT) >5 times the upper limit of normal or ALT >3 times the upper limit of normal plus total bilirubin >2 times the upper limit of normal
  • Hemoglobin level <90 g/dL at screening
  • Any severe condition that would limit life expectancy to less than 12 months
  • Major surgery, biopsy of a parenchymal organ, or serious trauma within the past 30 days
  • Incomplete staged PCI procedure (once completion of the staged PCI has occurred, the final PCI may become the index event)
  • CABG planned
  • Transient AF caused by a reversible disorder (e.g. thyrotoxicosis, pulmonary embolism, recent surgery)
  • Any condition other than non-valvular AF requiring long-term anticoagulation with VKAs such as moderate to severe mitral valve stenosis, mechanical heart valves, deep vein thrombosis, pulmonary embolism, or left ventricular thrombus
  • Known allergies, hypersensitivity, or intolerance to rivaroxaban or ticagrelor
  • Pregnant or planning to become pregnant while enrolled in this study, or unwilling to employ an investigator-approved method of birth control
  • Participation in a study with another investigational device or drug < four weeks
  • Is receiving systemic treatment with strong inhibitors of both cytochrome P450 (CYP) 3A4 and p-glycoprotein (P-gp; eg, the azole-antimycotic ketoconazole and the HIV-protease inhibitor ritonavir). Treatment with fluconazole is allowed.
  • CHADS-VASC <1

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7

Other trials in Canada

About this study

Official title: THE CAPITAL PCI AF Study: The Safety and Efficacy of Rivaroxaban and Ticagrelor for Patients With Atrial Fibrillation After Percutaneous Coronary Intervention

Currently, there is minimal data on the combination of rivaroxaban and ticagrelor in patients with atrial fibrillation (AF) managed with percutaneous coronary intervention (PCI). Furthermore, there exists significant controversy among physicians in the use of oral anticoagulants in conjunction with antiplatelet therapy in this population. The present recommendation is triple therapy (aspirin + clopidogrel + warfarin), which has been related to major bleeding complications. Previous studies have shown that ticagrelor has been proven to be more effective in reducing the rate of death, new heart attacks, or strokes than the previously recommended drug, clopidogrel, and studies have shown that less bleeding occurs with rivaroxaban than with warfarin. Therefore, it would be ideal to investigate the two potent drugs, ticagrelor and rivaroxaban, in combination in order to gain insight in the management of these high-risk patients.

The CAPITAL PCI AF study is a phase 3 Health Canada regulated interventional study involving the use of investigational drugs. It is a non-randomized, open-design study. The investigational team is studying the highly potent drug Ticagrelor, which is prescribed to participants receiving a stent placement, given in combination with Rivaroxaban, an oral anticoagulant recommended for patients with AF. The primary clinical endpoint is a safety outcome measuring bleeding complications in participants with AF treated within one year of the index PCI. The primary efficacy endpoint is measured by the clinical outcomes of death, stroke, non-central nervous system systemic embolism, myocardial infarction, and stent thrombosis within one year of the index PCI.

Being tested
Ticagrelor, Rivaroxaban
Keywords
percutaneous coronary intervention, bleeding, atrial fibrillation, Ticagrelor, Rivaroxaban
Medical subject headings
Atrial Fibrillation, Acute Coronary Syndrome, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TicagrelorDrug

    Ticagrelor 90 mg twice daily

  • RivaroxabanDrug

    Rivaroxaban 15 mg once daily (10mg for patients with moderate renal impairment, creatinine clearance: 30-50 mL/min by the Cockcoft Gault method)

Study groups in NCT03331484
Study groupRoleWhat they receive
Ticagrelor and RivaroxabanOtherAll participants will be prescribed ticagrelor 90 mg twice daily and rivaroxaban 15 mg once daily for a year.
Receives: Drug: Ticagrelor; Drug: Rivaroxaban

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite of TIMI Bleeds

    Composite of TIMI Major Bleed, Minor Bleed, and Bleeding requiring medical attention

    Measured: 12 months

Secondary outcomes (4)

  1. The frequency of the individual components of the primary endpoint

    Frequency of TIMI major, TIMI Minor, and TIMI bleeding requiring medical attention

    Measured: 12 months

  2. The composite of multiple adverse cardiovascular events (MACE)

    The composite of cardiovascular death and stroke events and its individual components

    Measured: 12 months

  3. The frequency of stent thrombosis

    Measured: 12 months

  4. All-cause mortality

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2017
  2. Study start1 Nov 2018
  3. Primary completion6 Jul 2023
  4. Study completion6 Jul 2023

Resources

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 3
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03331484
Sponsor's protocol ID
MRL-PCI AF
Acronym
CAPITAL PCI AF
Status last verified
Jan 2023
First submitted
31 Oct 2017
Last updated
6 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ticagrelor and Rivaroxaban in people with Atrial Fibrillation and Acute Coronary Syndrome, run by Ottawa Heart Institute Research Corporation 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 20 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 6 May 2026. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Composite of TIMI Bleeds (time frame: 12 months). 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 NCT03331484.

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 6 May 2026.

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