Acute Coronary SyndromePhase 2NCT00402597

Rivaroxaban in Combination With Aspirin Alone or With Aspirin and a Thienopyridine in Patients With Acute Coronary Syndromes (The ATLAS ACS TIMI 46 Trial)

A Phase 2 study testing Rivaroxaban in people with Acute Coronary Syndrome, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

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

The purpose of this study is to evaluate the safety of rivaroxaban in patients with recent acute coronary syndrome (ACS) and to assess the ability of rivaroxaban to reduce the occurrence of death, myocardial infarction (heart attack), repeat myocardial infarctions, stroke, and ischemia (inadequate blood supply to a… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Acute Coronary Syndrome
What is being tested?: Rivaroxaban
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 3,490 participants
Where: No sites listed yet
Study dates: Nov 2006to Oct 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Have symptoms suggestive of ACS that lasted at least 10 minutes at rest occurring within 7 days of randomization
Have a diagnosis of ST-elevation myocardial infarction or non-ST elevation myocardial infarction/unstable angina (ie, chest pain or discomfort) (ST elevation is an abnormal finding from an ECG test) with at least 1 protocol-defined high risk feature

Who cannot join

Active bleeding or high risk of bleeding or intracranial hemorrhage (bleeding within the skull enclosing the brain)
Need for continued anticoagulant therapy
Significantly impaired renal (kidney) or hepatic (liver) function
Severe concomitant diseases such as cardiogenic shock (heart damage that results in insufficient blood supply to other parts or organs of the body), refractory ventricular arrhythmias (irregular contractions of the heart unresponsive to treatment), or any severe condition that would limit life expectancy of the patient to less than 6 months

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Escalation and Dose-Confirmation Study to Evaluate the Safety and Efficacy of Rivaroxaban in Combination With Aspirin Alone or With Aspirin and a Thienopyridine in Subjects With Acute Coronary Syndromes

Read the detailed description

This is a randomized (patients will be assigned to study treatment by chance), double-blind (neither the patient nor the study doctor will know the identity of the assigned study treatment) study to evaluate the safety and efficacy of rivaroxaban (study drug) compared to placebo (a tablet identical in appearance to study drug but contains no active drug) in patients with acute coronary syndrome (ACS [a condition where blood flow in a blood vessel in the heart is restricted because of a blood clot]). Rivaroxaban is a drug that acts as a blood thinner and is being tested to see if it will be safe and effective in patients diagnosed ACS. The goal of this study is to identify the dose and dosing schedule (once-a-day or twice-a-day dosing) of rivaroxaban that will be safe and effective in preventing adverse cardiovascular outcomes such as death, myocardial infarctions (MI) including repeat myocardial infarction (reMI), stroke, or ischemia (inadequate blood supply to a local area) requiring revascularization (ie, the re-establishment of blood supply to a part or an organ) in patients with ACS who are receiving antiplatelet therapy (ie, aspirin alone or aspirin plus an approved thienopyridine, a type of drug such as clopidogrel that acts to inhibit the formation of blood clots). Approximately 3500 patients are planned to participate in the study for approximately 7 months. At study entry, all patients who are currently receiving treatment for ACS with antiplatelet therapy will be permitted to continue this therapy during the study. Patients will be enrolled and randomized to receive placebo, rivaroxaban administered as a once-daily dose, or rivaroxaban administered as a twice-daily dose at each dose level of rivaroxaban tested. Patients randomized at each dose level will continue to receive the same treatment for 6 months. Near the end of enrollment at the first dose level, available safety and efficacy data from patients will be assessed by an Operations Committee before enrolling and randomizing additional patients to the next higher dose level of rivaroxaban. Increasing dose levels of rivaroxaban are planned; however, progression to each higher dose level will be at the discretion of the Operations Committee. Patient safety will be monitored by evaluating adverse events reported, results from clinical laboratory tests, findings from electrocardiograms (ECGs) and vital signs measurements, findings from physical examinations, and the number of patients with protocol-defined major or minor bleeding, or bleeding requiring medical attention. All patients will take study drug or placebo tablets orally (by mouth) twice daily for 6 months starting at an initial total daily dose of 5 mg. Both once- and twice-daily dosing regimens will be tested at each rivaroxaban dose level planned.

Conditions: Acute Coronary Syndrome
Being tested: Rivaroxaban/Placebo, Placebo, Rivaroxaban
Keywords: Acute Coronary Syndrome (ACS), Myocardial Ischemia, Rivaroxaban (BAY59-7939), Anti-platelet agents, Aspirin, Thienopyridine, Clopidogrel
Medical subject headings: Acute Coronary Syndrome, Myocardial Ischemia

What participants receive

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

Rivaroxaban/PlaceboDrug
1 rivaroxaban tablet once daily (and 1 placebo tablet once daily) for 6 months. Safety at each dose level will be confirmed before additional patients are randomized to the next higher dose level.
PlaceboDrug
1 placebo tablet twice daily for 6 months.
RivaroxabanDrug
1 rivaroxaban tablet twice daily for 6 months. Safety at each dose level will be confirmed before additional patients are randomized to the next higher dose level.

Study groups in NCT00402597
Study group	Role	What they receive
001	Experimental	Rivaroxaban 1 rivaroxaban tablet twice daily for 6 months. Safety at each dose level will be confirmed before additional patients are randomized to the next higher dose level. Receives: Drug: Rivaroxaban
002	Experimental	Rivaroxaban/Placebo 1 rivaroxaban tablet once daily (and 1 placebo tablet once daily) for 6 months. Safety at each dose level will be confirmed before additional patients are randomized to the next higher dose level. Receives: Drug: Rivaroxaban/Placebo
003	Placebo comparator	Placebo 1 placebo tablet twice daily for 6 months. Receives: Drug: Placebo

What is being measured

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

Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events (Primary Safety)
The number of patients with a first occurrence of a TIMI clinically significant bleeding event that occurred from the time of randomization to the time of the last patient contact. TIMI clinically significant bleeding events included TIMI minor bleeding events, TIMI major bleeding events, or any bleeding that required medical attention.
Measured: Day 1 to Day 210
The Composite Endpoint of All Cause Death, Myocardial Infarction (MI) (Including Repeat MI), Stroke (Ischemic, Hemorrhagic or Unknown), or Severe Recurrent Ischemia Requiring Revascularization (Primary Efficacy)
The number of patients who died due to any cause or had a first occurrence of MI (including repeat MI) or stroke (ischemic, hemorrhagic or unknown) or severe recurrent ischemia requiring revascularization from the time of randomization to the last date of patient contact.
Measured: Day 1 to Day 210

Secondary outcomes (4)

The Composite Endpoint of Death (All Cause), Myocardial Infarction (MI) (or Repeat MI), or Stroke
The number of patients who died due to any cause or had a first occurrence of MI (or repeat MI) or stroke from the time of randomization to the last date of patient contact.
Measured: Day 1 to Day 210
The Composite Endpoint of Cardiovascular Death, Myocardial Infarction (MI), or Stroke
The number of patients with the composite endpoint of cardiovascular death or MI or stroke that occurred from the time of randomization to the last date of patient contact.
Measured: Day 1 to Day 210
The Number of Deaths (All Cause)
The number of patients who died due to any cause from the time of randomization to the last date of patient contact.
Measured: Day 1 to Day 210
The Composite Endpoint of Death (All Cause), MI (or reMI), Stroke, Severe Recurrent Ischemia Requiring Revascularization, or Thrombolysis in Myocardial Infarction (TIMI) (Major or Minor Bleeding) to Assess the Net Clinical Benefit
The number of patients who died due to any cause or had a first occurrence of MI (or repeat MI), or stroke, or severe recurrent ischemia requiring revascularization, or TIMI (major or minor bleeding) from the time of randomization to the last date of patient contact to assess the net clinical benefit of rivaroxaban.
Measured: Day 1 to Day 210

Timeline

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

Nov 2006Oct 2008

First posted22 Nov 2006 (estimated)
Study startNov 2006
Primary completionOct 2008
Study completionOct 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Acute Coronary SyndromeStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 3,490 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00402597
Sponsor's protocol ID: CR013417
Other IDs: 39039039ACS2001
Status last verified: Sep 2012
First submitted: 21 Nov 2006
Last updated: 4 Oct 2012
Results posted: Yes, on ClinicalTrials.gov

Publications

Mega JL, Braunwald E, Mohanavelu S, Burton P, Poulter R, Misselwitz F, Hricak V, Barnathan ES, Bordes P, Witkowski A, Markov V, Oppenheimer L, Gibson CM; ATLAS ACS-TIMI 46 study group. Rivaroxaban versus placebo in patients with acute coronary syndromes (ATLAS ACS-TIMI 46): a randomised, double-blind, phase II trial. Lancet. 2009 Jul 4;374(9683):29-38. doi: 10.1016/S0140-6736(09)60738-8. Epub 2009 Jun 17.
PubMed 19539361
Gibson WJ, Nafee T, Travis R, Yee M, Kerneis M, Ohman M, Gibson CM. Machine learning versus traditional risk stratification methods in acute coronary syndrome: a pooled randomized clinical trial analysis. J Thromb Thrombolysis. 2020 Jan;49(1):1-9. doi: 10.1007/s11239-019-01940-8.
PubMed 31535314
Gibson CM, Mega JL, Burton P, Goto S, Verheugt F, Bode C, Plotnikov A, Sun X, Cook-Bruns N, Braunwald E. Rationale and design of the Anti-Xa therapy to lower cardiovascular events in addition to standard therapy in subjects with acute coronary syndrome-thrombolysis in myocardial infarction 51 (ATLAS-ACS 2 TIMI 51) trial: a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rivaroxaban in subjects with acute coronary syndrome. Am Heart J. 2011 May;161(5):815-821.e6. doi: 10.1016/j.ahj.2011.01.026.
PubMed 21570509

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 4 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Escalation and Dose-Confirmation Study to Evaluate the Safety and Efficacy of Rivaroxaban in Combination With Aspirin Alone or With Aspirin and a Thienopyridine in Subjects With Acute Coronary Syndromes
ClinicalTrials.gov ID: NCT00402597
Acronym / sponsor ID: CR013417
Conditions: Acute Coronary Syndrome
Keywords: Acute Coronary Syndrome (ACS), Myocardial Ischemia, Rivaroxaban (BAY59-7939), Anti-platelet agents, Aspirin, Thienopyridine, Clopidogrel
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,490 participants (actual)
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
Collaborators: Bayer
Study start: Nov 2006
Primary completion: Oct 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 22 Nov 2006 (estimated)
Results: Posted 29 Aug 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
001	Experimental	Drug: RivaroxabanRivaroxaban 1 rivaroxaban tablet twice daily for 6 months. Safety at each dose level will be confirmed before additional patients are randomized to the next higher dose level.
002	Experimental	Drug: Rivaroxaban/PlaceboRivaroxaban/Placebo 1 rivaroxaban tablet once daily (and 1 placebo tablet once daily) for 6 months. Safety at each dose level will be confirmed before additional patients are randomized to the next higher dose level.
003	Placebo comparator	Drug: PlaceboPlacebo 1 placebo tablet twice daily for 6 months.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Have symptoms suggestive of ACS that lasted at least 10 minutes at rest occurring within 7 days of randomization
Have a diagnosis of ST-elevation myocardial infarction or non-ST elevation myocardial infarction/unstable angina (ie, chest pain or discomfort) (ST elevation is an abnormal finding from an ECG test) with at least 1 protocol-defined high risk feature

Key exclusion criteria (4 listed)

Active bleeding or high risk of bleeding or intracranial hemorrhage (bleeding within the skull enclosing the brain)
Need for continued anticoagulant therapy
Significantly impaired renal (kidney) or hepatic (liver) function
Severe concomitant diseases such as cardiogenic shock (heart damage that results in insufficient blood supply to other parts or organs of the body), refractory ventricular arrhythmias (irregular contractions of the heart unresponsive to treatment), or any severe condition that would limit life expectancy of the patient to less than 6 months

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
Rivaroxaban/Placebo1 rivaroxaban tablet once daily (and 1 placebo tablet once daily) for 6 months. Safety at each dose level will be confirmed before additional patients are randomized to the next higher dose level.	Drug	002
Placebo1 placebo tablet twice daily for 6 months.	Drug	003
Rivaroxaban1 rivaroxaban tablet twice daily for 6 months. Safety at each dose level will be confirmed before additional patients are randomized to the next higher dose level.	Drug	001

Primary outcome

Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events (Primary Safety)
Time frame: Day 1 to Day 210
The number of patients with a first occurrence of a TIMI clinically significant bleeding event that occurred from the time of randomization to the time of the last patient contact. TIMI clinically significant bleeding events included TIMI minor bleeding events, TIMI major bleeding events, or any bleeding that required medical attention.
The Composite Endpoint of All Cause Death, Myocardial Infarction (MI) (Including Repeat MI), Stroke (Ischemic, Hemorrhagic or Unknown), or Severe Recurrent Ischemia Requiring Revascularization (Primary Efficacy)
Time frame: Day 1 to Day 210
The number of patients who died due to any cause or had a first occurrence of MI (including repeat MI) or stroke (ischemic, hemorrhagic or unknown) or severe recurrent ischemia requiring revascularization from the time of randomization to the last date of patient contact.

4 secondary outcomes

The Composite Endpoint of Death (All Cause), Myocardial Infarction (MI) (or Repeat MI), or Stroke
Time frame: Day 1 to Day 210
The Composite Endpoint of Cardiovascular Death, Myocardial Infarction (MI), or Stroke
Time frame: Day 1 to Day 210
The Number of Deaths (All Cause)
Time frame: Day 1 to Day 210
The Composite Endpoint of Death (All Cause), MI (or reMI), Stroke, Severe Recurrent Ischemia Requiring Revascularization, or Thrombolysis in Myocardial Infarction (TIMI) (Major or Minor Bleeding) to Assess the Net Clinical Benefit
Time frame: Day 1 to Day 210

Results and safety

Results posted to the registry on 29 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	1,153	962
Riva 5 mg Total Daily Dose (TDD)	307	261
Riva 10 mg TDD	1,046	834
Riva 15 mg TDD	353	279
Riva 20 mg TDD	603	479

Primary outcome: Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events (Primary Safety)

Time frame: Day 1 to Day 210. Number. Unit: Patients

Measure	Placebo n = 1153	Riva 5 mg Total Daily Dose (TDD) n = 307	Riva 10 mg TDD n = 1046	Riva 15 mg TDD n = 353	Riva 20 mg TDD n = 603
Value	36	17	109	43	89

Population analysed: The safety population consisted of all randomized patients who took at least 1 dose of study medication after randomization during the double-blind treatment period.

Primary outcome: The Composite Endpoint of All Cause Death, Myocardial Infarction (MI) (Including Repeat MI), Stroke (Ischemic, Hemorrhagic or Unknown), or Severe Recurrent Ischemia Requiring Revascularization (Primary Efficacy)

Time frame: Day 1 to Day 210. Number. Unit: Patients

Measure	Placebo n = 1160	Riva 5 mg Total Daily Dose (TDD) n = 308	Riva 10 mg TDD n = 1056	Riva 15 mg TDD n = 356	Riva 20 mg TDD n = 611
Value	83	23	55	27	36

Population analysed: The intent-to-treat (ITT) population consisted of all patients who were randomized to treatment, regardless of study drug intake.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	247 of 1,153 (21.4%)	223 of 1,153 (19.3%)	Not reported
Riva 5 mg Total Daily Dose (TDD)	74 of 307 (24.1%)	67 of 307 (21.8%)	Not reported
Riva 10 mg TDD	208 of 1,046 (19.9%)	293 of 1,046 (28%)	Not reported
Riva 15 mg TDD	72 of 353 (20.4%)	108 of 353 (30.6%)	Not reported
Riva 20 mg TDD	128 of 603 (21.2%)	148 of 603 (24.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19539361Mega JL, Braunwald E, Mohanavelu S, Burton P, Poulter R, Misselwitz F, Hricak V, Barnathan ES, Bordes P, Witkowski A, Markov V, Oppenheimer L, Gibson CM; ATLAS ACS-TIMI 46 study group. Rivaroxaban versus placebo in patients with acute coronary syndromes (ATLAS ACS-TIMI 46): a randomised, double-blind, phase II trial. Lancet. 2009 Jul 4;374(9683):29-38. doi: 10.1016/S0140-6736(09)60738-8. Epub 2009 Jun 17.
Derived from this study: PubMed 31535314Gibson WJ, Nafee T, Travis R, Yee M, Kerneis M, Ohman M, Gibson CM. Machine learning versus traditional risk stratification methods in acute coronary syndrome: a pooled randomized clinical trial analysis. J Thromb Thrombolysis. 2020 Jan;49(1):1-9. doi: 10.1007/s11239-019-01940-8.
Derived from this study: PubMed 21570509Gibson CM, Mega JL, Burton P, Goto S, Verheugt F, Bode C, Plotnikov A, Sun X, Cook-Bruns N, Braunwald E. Rationale and design of the Anti-Xa therapy to lower cardiovascular events in addition to standard therapy in subjects with acute coronary syndrome-thrombolysis in myocardial infarction 51 (ATLAS-ACS 2 TIMI 51) trial: a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rivaroxaban in subjects with acute coronary syndrome. Am Heart J. 2011 May;161(5):815-821.e6. doi: 10.1016/j.ahj.2011.01.026.

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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.

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rivaroxaban in people with Acute Coronary Syndrome, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

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 2 inclusion and 4 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 4 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events (Primary Safety) (time frame: Day 1 to Day 210). The study lists 2 primary outcomes in all. 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 NCT00402597, which also lists 3 linked publications.

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 4 Oct 2012.