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Coronary Artery DiseasePhase 3ALPHEUSNCT02617290

Assessment of Loading With the P2Y12 Inhibitor Ticagrelor or Clopidogrel to Halt Ischemic Events in Patients Undergoing Elective Coronary Stenting

A Phase 3 study testing Ticagrelor and Clopidogrel in people with Coronary Artery Disease and Myocardial Ischemia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

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 new P2Y12 inhibitors prasugrel (Efient®-Effient®) and ticagrelor (Brilique®-Brilinta®) have shown promising results in the respective TRITON and PLATO trials making of prasugrel and ticagrelor recommended first line treatments for acute coronary syndrome ACS (ESC Guidelines: Class 1 LOE B). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ticagrelor and Clopidogrel
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,900 participants
Where
1 siteFrance
Study dates
9 Jan 2017to 15 Sep 2020
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

  • Male or female ≥18 years of age
  • Having at least one high-risk feature (Age > 75, Renal insufficiency (Clearance below 60ml/min calculated with Cockcroft-Gault formula), Diabetes Mellitus, Overweight (BMI >30), History of ACS (in the past 12 months) including UA/NSTEMI and STEMI, LVEF < 40% and/or prior episode of heart failure, Multivessel disease (2 or 3 V), Multiple stents needed defined as i) more than one stent implanted in one vessel or ii) more than 2 stents in 2 or more vessels, or iii) total stent length envisioned > 30mm, Left main stenting, Bifurcation stenting (whatever the technique), ACC/AHA type B2 or C lesion , Stenting of venous or arterial coronary graft).
  • Undergoing non-emergent single or multiple sites/vessels PCI during the same procedure)
  • Negative troponin before enrolment (according to local measurement - hsTn preferably)
  • Informed consent obtained in writing at enrolment into the study

Who cannot join

  • Women of child-bearing potential (ie, those who are not chemically or surgically sterilised or who are not post-menopause) who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator OR women who have a positive pregnancy test at randomisation OR women who are breast-feeding
  • Thrombolytic therapy within the previous 24 hours
  • Undergoing primary PCI for ongoing STEMI
  • Undergoing rescue PCI after failed thrombolysis
  • Any other elective PCI scheduled within the following 30 days after the index PCI
  • History of intracranial haemorrhage at any time
Show all 20Show fewer
  • Increased bleeding risk: intracranial tumor or aneurysm; recent trauma or major surgery (< 1 month) (including bypass surgery), active gastrointestinal, active bleeding
  • Uncontrolled arterial hypertension (defined as a systolic BP ≥180 mmHg and/or diastolic BP ≥100 mmHg)
  • Recent (<48 hours) or planned spinal/epidural anesthesia or puncture
  • Impaired haemostasis such as known International Normalized Ratio (INR) >1.5; past or present bleeding disorder (including congenital bleeding disorders such as von Willebrand's disease or hemophilia, acquired bleeding disorders, and unexplained clinically significant bleeding disorders), thrombocytopenia (platelet count <100,000/μL)
  • Known severe and moderated hepatic impairment
  • Treatment with oral anticoagulant therapy within 72 hours prior to inclusion or current need for oral anticoagulant therapy in the next month.
  • Use of abciximab within the previous 7 days or, tirofiban or eptifibatide within the past 12 hours of index PCI
  • Prohibited treatments (see section 8.3)
  • Inability to give informed consent or high likelihood of being unavailable for follow-up
  • Participation in another clinical research protocol with other investigational agents or devices within the previous 30 days, planned use of investigational drugs or devices, or previous enrolment in this trial (routine care authorized)
  • Known intolerance to clopidogrel or ticagrelor
  • Hypersensitivity to ticagrelor or its excipients
  • Hypersensitivity to clopidogrel or its excipients
  • Patient on prasugrel or ticagrelor before the procedure

Trial locations and contacts

1 site in 1 country.

France1 site

  • Institut de Cardiologie - USIC - Hôpital Pitié-Salpêtrière

    Paris, 75013

Other trials in France

About this study

Official title: Assessment of Loading With the P2Y12 Inhibitor Ticagrelor or Clopidogrel to Halt Ischemic Events in Patients Undergoing Elective Coronary Stenting: The ALPHEUS Study

The new P2Y12 inhibitors prasugrel (Efient®-Effient®) and ticagrelor (Brilique®-Brilinta®) have shown promising results in the respective TRITON and PLATO trials making of prasugrel and ticagrelor recommended first line treatments for acute coronary syndrome ACS (ESC Guidelines: Class 1 LOE B). These two drugs showed superiority over clopidogrel in ACS patients undergoing percutaneous coronary intervention (PCI), by the dramatic diminution of stent thrombosis, the reduction in death or Myocardial Infarction (MI) as well as the reduction in death in a meta-analysis.

The field of elective PCI (stable patients) has not been studied with these 2 new drugs and clopidogrel remains the standard of care. However, off-label use of prasugrel and ticagrelor is increasing in patients undergoing high risk elective PCI (left main, diabetics, multiple stenting, high risk of stent thrombosis, no clopidogrel pretreatment…) but is not supported by scientific evidence. More than half of PCI patients undergo elective stenting for proven ischemia and/or stable angina, a relatively safe procedure with the use of the latest generation of stents. However complications remain either frequent when considering PCI-related myonecrosis/myocardial injury that have been linked to the prognosis of patients or rare but serious when considering stent thrombosis, Q wave MI or stroke, leaving room for improvement with these two newest drugs.

The investigators propose to perform a multicenter international study in stable patients undergoing elective PCI with a randomization between clopidogrel and ticagrelor. The investigators hypothesize that this study will show superiority of the new P2Y12 inhibitor over clopidogrel in elective PCI on the primary ischemic endpoint (peri-procedural MI and myocardial injury) without significant excess bleeding (BARC definition).

Being tested
Ticagrelor, Clopidogrel
Keywords
Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI)
Medical subject headings
Coronary Artery Disease, Myocardial Ischemia, Myocardial Infarction, Cardiovascular Diseases

What participants receive

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

  • TicagrelorDrug

    Also called Brilique, Brilinta

    Ticagrelor Loading dose of 180mg given after angiography and before PCI , followed by a 30 days treatment with the maintenance dose of 90mg bid.

  • ClopidogrelDrug

    Also called Plavix

    Clopidogrel Loading dose of 300 or 600mg given after angiography and before PCI , followed by a 30 days treatment with the maintenance dose of 75mg per day.

Study groups in NCT02617290
Study groupRoleWhat they receive
Ticagrelor ArmExperimentalTicagrelor is an oral antiplatelet agent which was approved for use in the European Union by the European Commission on December 3, 2010. The drug was approved by the US Food and Drug Administration on July 20, 2011. It is available as round, yellow tablets (90 mg). The standard dose is 90 mg twice a day during the maintenance phase and 180 mg once for the loading dose. It is approved for duration of 12 month in ACS patients and will be used for duration of one month in the ALPHEUS Study.
Receives: Drug: Ticagrelor
Clopidogrel ArmActive comparatorClopidoprel is an oral antiplatelet agent which was approved for use in the European Union by the European Commission in 1997 and available as generic since 2007. The standard dose of clopidogrel is one 75 mg tablet once a day. The dosage for the loading dose is normally 300 mg but 600 mg is also used. Clopidogrel is the standard of care for PCI at the moment.
Receives: Drug: Clopidogrel

What is being measured

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

  1. Ischemic Episode

    The rate of PCI-related myocardial infarction (MI type 4) or injury (I) within 48 hours (or at hospital discharge if earlier) of elective PCI/stent

    Measured: 48 hours (hospital discharge if earlier)

Secondary outcomes (1)

  1. Bleeding Episode

    The rate of major bleeding events as assessed by the BARC criteria (BARC type 3 or 5) at 48 hours (or discharge if it occurs earlier)

    Measured: 48 hours (or discharge if it occurs earlier)

Timeline

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

  1. First posted30 Nov 2015 (estimated)
  2. Study start9 Jan 2017
  3. Primary completion29 May 2020
  4. Study completion15 Sep 2020

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,900 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02617290
Sponsor's protocol ID
P141103
Acronym
ALPHEUS
Status last verified
Oct 2020
First submitted
15 Sep 2015
Last updated
14 Oct 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Giovachini L, Ferrante A, Guedeney P, Rahoual G, Procopi N, Barthelemy O, Kerneis M, Zeitouni M, El Kasty M, Cayla G, Beygui F, Range G, Motovska Z, Laredo M, Dumaine R, Ducrocq G, Rouanet S, Portal JJ, Vicaut E, Montalescot G, Silvain J; ALPHEUS investigators* of the ACTION Group. Impacts of stent characteristics on periprocedural ischemic events in elective PCI: the ALPHEUS-stents study. Int J Cardiol. 2026 Aug 1;456:134506. doi: 10.1016/j.ijcard.2026.134506. Epub 2026 Apr 16.

    PubMed 41999954

  • Zeitouni M, Montalescot G, Roule V, Guedeney P, Georges JL, Bellemain-Appaix A, Hauguel-Moreau M, Le Breton H, Saint-Etienne C, Caussin C, Montsegu JJ, Maillard L, Isaaz K, Cuisset T, Bressollette E, Schiele F, Cayla G, Beygui F, Range G, Motovska Z, Portal JJ, Vicaut E, Collet JP, Silvain J; ALPHEUS Investigators of the ACTION Group. Definition and Prediction of Periprocedural Myocardial Infarction in Elective Percutaneous Coronary Intervention: The ALPHEUS-MI Study. Can J Cardiol. 2026 Feb 27:S0828-282X(26)00140-6. doi: 10.1016/j.cjca.2026.02.023. Online ahead of print.

    PubMed 41763360

  • Silvain J, Lattuca B, Beygui F, Range G, Motovska Z, Dillinger JG, Boueri Z, Brunel P, Lhermusier T, Pouillot C, Larrieu-Ardilouze E, Boccara F, Labeque JN, Guedeney P, El Kasty M, Laredo M, Dumaine R, Ducrocq G, Collet JP, Cayla G, Blanchart K, Kala P, Vicaut E, Montalescot G; ALPHEUS investigators. Ticagrelor versus clopidogrel in elective percutaneous coronary intervention (ALPHEUS): a randomised, open-label, phase 3b trial. Lancet. 2020 Nov 28;396(10264):1737-1744. doi: 10.1016/S0140-6736(20)32236-4. Epub 2020 Nov 14.

    PubMed 33202219

  • Silvain J, Cayla G, Beygui F, Range G, Lattuca B, Collet JP, Dillinger JG, Boueri Z, Brunel P, Pouillot C, Boccara F, Christiaens L, Labeque JN, Lhermusier T, Georges JL, Bellemain-Appaix A, Le Breton H, Hauguel-Moreau M, Saint-Etienne C, Caussin C, Jourda F, Motovska Z, Guedeney P, El Kasty M, Laredo M, Dumaine R, Ducrocq G, Vicaut E, Montalescot G; ALPHEUS study group. Blunting periprocedural myocardial necrosis: Rationale and design of the randomized ALPHEUS study. Am Heart J. 2020 Jul;225:27-37. doi: 10.1016/j.ahj.2020.04.017. Epub 2020 Apr 29.

    PubMed 32473356

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ticagrelor and Clopidogrel in people with Coronary Artery Disease and Myocardial Ischemia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

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 14 Oct 2020. 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 France. 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?

Ischemic Episode (time frame: 48 hours (hospital discharge if earlier)). 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 NCT02617290, which also lists 4 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 14 Oct 2020.

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