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Acute Coronary Syndrome (ACS)Phase 4ISAR-REACT 5NCT01944800

Prospective, Randomized Trial of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome

A Phase 4 study testing Ticagrelor and Prasugrel in people with Acute Coronary Syndrome (ACS), run by Deutsches Herzzentrum Muenchen at 19 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

Aim of the randomized, open-label, multicenter ISAR-REACT 5 trial is to assess whether ticagrelor is superior to prasugrel in patients with acute coronary syndrome and planned invasive strategy in terms of clinical outcomes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Coronary Syndrome (ACS)
What is being tested?
Ticagrelor and Prasugrel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,018 participants
Where
19 sitesin 2 countries
Study dates
15 Sep 2013to Sep 2021
Phase
Phase 4
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

Major Inclusion Criteria:

Hospitalization for an acute coronary syndrome (ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction or unstable angina pectoris) with planned invasive strategy

Major Exclusion Criteria:

  1. intolerance of or allergy to ticagrelor or prasugrel
  2. history of any stroke, transient ischemic attack or intracranial bleeding
  3. known intracranial neoplasm, intracranial arteriovenous malformation or intracranial aneurysm
  4. active bleeding, clinical findings, that in the judgement of the investigator are associated with an increased risk of bleeding
  5. fibrin-specific fibrinolytic therapy less than 24 h before randomization, non-fibrin-specific fibrinolytic therapy less than 48 h before randomization
  6. known platelet count < 100.000/μL at the time of screening
  7. known anemia (hemoglobin <10 g/dL) at the time of screening
  8. oral anticoagulation that cannot be safely discontinued for the duration of the study
  9. INR known to be greater than 1.5 at the time of screening
  10. chronic renal insufficiency requiring dialysis
  11. moderate or severe hepatic dysfunction (Child Pugh B or C)
  12. increased risk of bradycardia events (Sick Sinus, AV block grade II or III, bradycardia-induced syncope)
  13. index event is an acute complication (< 30 days) of PCI
  14. concomitant medical illness that in the opinion of the investigator is associated with a life expectancy < 1 year
  15. concomitant oral or i.v. therapy with strong CYP3A Inhibitors (e.g. ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, grapefruit juice > 1 L/d), CYP3A substrates with narrow therapeutic indices (e.g. cyclosporine, quinidine), or strong CYP3A inducers (e.g. rifampin/rifampicin, phenytoin, carbamazepine, dexamethason, phenobarbital ) that cannot be safely discontinued
  16. ≥1 doses of ticagrelor or prasugrel within 5 days before randomisation
  17. no written informed consent
  18. participation in another investigational drug study
  19. previous enrolment in this study
  20. for women of childbearing potential no negative pregnancy test and no agree to use reliable method of birth control during the study
  21. Pregnancy, giving birth within the last 90 days, or lactation
  22. inability to cooperate with protocol requirements

Trial locations and contacts

19 sites in 2 countries.

19 sites in 2 countries

Germany17 sites

  • Universitäts-Herzzentrum Freiburg/ Bad Krozingen

    Bad Krozingen, Baden-Wurttemberg, 79189

  • Kerckhoff-Klinik GmbH, Abteilung für Kardiologie

    Bad Nauheim, Hesse, 61231

  • Segeberger Kliniken GmbH

    Bad Segeberg, Schleswig-Holstein, 23795

  • Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin

    Berlin, 12203

  • Charité Universitätsmedizin Berlin, Campus Virchow-Klinik

    Berlin, 13353

  • Klinikum Landkreis Erding

    Erding, Bavaria, 85435

  • Universitätsmedizin Göttingen, Herzzentrum

    Göttingen, Lower Saxony, 37099

  • Universitäts-Klinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

  • Universitätsklinikum Schleswig-Holstein, Klinik für Innere Medizin III, Campus Kiel

    Kiel, Schleswig-Holstein, 24105

  • Universitätsklinikum Mannheim

    Mannheim, Baden-Wurttemberg, 68167

  • Deutsches Herzzentrum Munich

    München, Bavaria, 80636

  • Klinikum rechts der Isar, 1. Medizinische Klinik und Poliklinik

    München, Bavaria, 81675

  • Klinikum Neuperlach

    München, Bavaria, 81737

  • Universitätsklinikum Regensburg

    Regensburg, Bavaria, 93042

  • Klinikum Traunstein

    Traunstein, Bavaria, 83278

  • Universitätsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081

  • Herzzentrum Wuppertal

    Wuppertal, North Rhine-Westphalia, 42117

Other trials in Germany

Italy2 sites

  • Careggi University Hospital, Invasive Cardiology Division

    Florence, 50141

  • Spaziani Hospital Frosinone

    Frosinone, 03100

Other trials in Italy

About this study

Official title: Prospective, Randomized Trial of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome - Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment (ISAR-REACT) 5

Aim of the randomized, open-label, multicenter ISAR-REACT 5 trial is to assess whether ticagrelor is superior to prasugrel in patients with acute coronary syndrome and planned invasive strategy in terms of clinical outcomes.

Being tested
Ticagrelor, Prasugrel
Keywords
Ticagrelor, Prasugrel, Acute coronary syndrome, Percutaneous coronary intervention
Medical subject headings
Acute Coronary Syndrome

What participants receive

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

  • TicagrelorDrug

    Also called Brilique

    Loading dose of 180 mg, followed by maintenance dose of 180 mg per day

  • PrasugrelDrug

    Also called Efient

    Loading dose of 60 mg, followed by maintenance dose of 10 mg/day or 5 mg/day in patients =/> 75 years or < 60 kg

Study groups in NCT01944800
Study groupRoleWhat they receive
TicagrelorExperimentalNot described
Receives: Drug: Ticagrelor
PrasugrelActive comparatorNot described
Receives: Drug: Prasugrel

What is being measured

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

  1. Composite of death, myocardial infarction or stroke

    Measured: 12 months

Secondary outcomes (5)

  1. Bleeding

    Bleeding according to BARC

    Measured: 12 months

  2. Mortality

    Death for any cause

    Measured: 12 months

  3. Stroke

    Stroke

    Measured: 12 months

  4. Myocardial Infarction

    Measured: 12 months

  5. Stent Thrombosis

    Stent thrombosis according to ARC

    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 posted18 Sep 2013 (estimated)
  2. Study start15 Sep 2013
  3. Primary completionJul 2019
  4. Study completionSep 2021

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
4,018 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01944800
Sponsor's protocol ID
GE IDE 00113
Other IDs
2013-002272-40
Acronym
ISAR-REACT 5
Status last verified
Feb 2023
First submitted
13 Sep 2013
Last updated
6 Feb 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • Bongiovanni D, Schreiner N, Gosetti R, Mayer K, Angiolillo DJ, Sibbing D, Holdenrieder S, Anetsberger A, von Scheidt M, Schunkert H, Laugwitz KL, Schupke S, Kastrati A, Fegers-Wustrow I, Bernlochner I. Immature Platelet Fraction Predicts Adverse Events in Patients With Acute Coronary Syndrome: the ISAR-REACT 5 Reticulated Platelet Substudy. Arterioscler Thromb Vasc Biol. 2023 Feb;43(2):e83-e93. doi: 10.1161/ATVBAHA.122.318614. Epub 2022 Dec 22.

    PubMed 36546322

  • Lahu S, Scalamogna M, Ndrepepa G, Menichelli M, Valina C, Hemetsberger R, Witzenbichler B, Bernlochner I, Joner M, Xhepa E, Hapfelmeier A, Kufner S, Sager HB, Mayer K, Kessler T, Laugwitz KL, Richardt G, Schunkert H, Neumann FJ, Kastrati A, Cassese S. Prior Myocardial Infarction and Treatment Effect of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndromes - A Post-hoc Analysis of the ISAR-REACT 5 Trial. J Am Heart Assoc. 2022 Dec 20;11(24):e027257. doi: 10.1161/JAHA.122.027257. Epub 2022 Dec 14.

    PubMed 36515247

  • Aytekin A, Coughlan JJ, Ndrepepa G, Cassese S, Lahu S, Kufner S, Mayer K, Xhepa E, Gewalt S, Joner M, Hapfelmeier A, Angiolillo DJ, Menichelli M, Richardt G, Neumann FJ, Schunkert H, Kastrati A. The effect of a Prasugrel- vs. a Ticagrelor-based strategy on total ischaemic and bleeding events in patients with acute coronary syndromes. Eur Heart J Cardiovasc Pharmacother. 2023 Apr 10;9(3):231-239. doi: 10.1093/ehjcvp/pvac067.

    PubMed 36434779

  • Lahu S, Presch A, Ndrepepa G, Menichelli M, Valina C, Hemetsberger R, Witzenbichler B, Bernlochner I, Joner M, Xhepa E, Hapfelmeier A, Kufner S, Rifatov N, Sager HB, Mayer K, Kessler T, Laugwitz KL, Richardt G, Schunkert H, Neumann FJ, Sibbing D, Angiolillo DJ, Kastrati A, Cassese S. Ticagrelor or Prasugrel in Patients With Acute Coronary Syndrome and High Bleeding Risk. Circ Cardiovasc Interv. 2022 Oct;15(10):e012204. doi: 10.1161/CIRCINTERVENTIONS.122.012204. Epub 2022 Oct 18.

    PubMed 36256695

  • Behnes M, Lahu S, Ndrepepa G, Menichelli M, Mayer K, Wohrle J, Bernlochner I, Gewalt S, Witzenbichler B, Hochholzer W, Sibbing D, Cassese S, Angiolillo DJ, Hemetsberger R, Valina C, Muller A, Kufner S, Hamm CW, Xhepa E, Hapfelmeier A, Sager HB, Joner M, Fusaro M, Richardt G, Laugwitz KL, Neumann FJ, Schunkert H, Schupke S, Kastrati A, Akin I. Ticagrelor or prasugrel in patients with acute coronary syndrome with off-hour versus on-hour presentation: a subgroup analysis of the ISAR-REACT 5 trial. Clin Res Cardiol. 2023 Apr;112(4):518-528. doi: 10.1007/s00392-022-02040-z. Epub 2022 Jul 5.

    PubMed 35789430

  • Hemetsberger R, Richardt G, Lahu S, Valina C, Menichelli M, Abdelghani M, Wohrle J, Toelg R, Witzenbichler B, Mankerious N, Liebetrau C, Bernlochner I, Hamm CW, Allali A, Joner M, Fusaro M, Xhepa E, Hapfelmeier A, Kufner S, Sager HB, Schupke S, Laugwitz KL, Schunkert H, Neumann FJ, Kastrati A, Cassese S. Access Route and Clinical Outcomes After Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome Undergoing Invasive Treatment Strategy. Cardiovasc Revasc Med. 2022 Aug;41:122-128. doi: 10.1016/j.carrev.2021.12.029. Epub 2022 Jan 3.

    PubMed 35045943

  • Lahu S, Behnes M, Ndrepepa G, Neumann FJ, Sibbing D, Bernlochner I, Menichelli M, Mayer K, Richardt G, Gewalt S, Angiolillo DJ, Coughlan JJ, Aytekin A, Witzenbichler B, Hochholzer W, Cassese S, Kufner S, Xhepa E, Sager HB, Joner M, Fusaro M, Laugwitz KL, Schunkert H, Schupke S, Kastrati A, Akin I. Body mass index and efficacy and safety of ticagrelor versus prasugrel in patients with acute coronary syndromes. Rev Esp Cardiol (Engl Ed). 2022 Sep;75(9):747-755. doi: 10.1016/j.rec.2021.11.007. Epub 2021 Dec 24. English, Spanish.

    PubMed 34961732

  • Ndrepepa G, Neumann FJ, Menichelli M, Bernlochner I, Richardt G, Wohrle J, Witzenbichler B, Mayer K, Cassese S, Gewalt S, Xhepa E, Kufner S, Sager HB, Joner M, Ibrahim T, Laugwitz KL, Schunkert H, Schupke S, Kastrati A. Assessment of Impact of Patient Recruitment Volume on Risk Profile, Outcomes, and Treatment Effect in a Randomized Trial of Ticagrelor Versus Prasugrel in Acute Coronary Syndromes. J Am Heart Assoc. 2021 Nov 16;10(22):e021418. doi: 10.1161/JAHA.121.021418. Epub 2021 Nov 15.

    PubMed 34779234

  • Ndrepepa G, Holdenrieder S, Neumann FJ, Lahu S, Cassese S, Joner M, Xhepa E, Kufner S, Wiebe J, Laugwitz KL, Gewalt S, Schunkert H, Kastrati A. Prognostic value of glomerular function estimated by Cockcroft-Gault creatinine clearance, MDRD-4, CKD-EPI and European Kidney Function Consortium equations in patients with acute coronary syndromes. Clin Chim Acta. 2021 Dec;523:106-113. doi: 10.1016/j.cca.2021.09.007. Epub 2021 Sep 13.

    PubMed 34529983

  • Coughlan JJ, Aytekin A, Ndrepepa G, Schupke S, Bernlochner I, Mayer K, Neumann FJ, Menichelli M, Richardt G, Wohrle J, Xhepa E, Kufner S, Sager HB, Joner M, Ibrahim T, Fusaro M, Laugwitz KL, Schunkert H, Kastrati A, Cassese S. Twelve-month clinical outcomes in patients with acute coronary syndrome undergoing complex percutaneous coronary intervention: insights from the ISAR-REACT 5 trial. Eur Heart J Acute Cardiovasc Care. 2021 Dec 18;10(10):1117-1124. doi: 10.1093/ehjacc/zuab077.

    PubMed 34468709

  • Wohrle J, Seeger J, Lahu S, Mayer K, Bernlochner I, Gewalt S, Menichelli M, Witzenbichler B, Hochholzer W, Sibbing D, Cassese S, Angiolillo DJ, Hemetsberger R, Valina C, Kufner S, Xhepa E, Hapfelmeier A, Sager HB, Joner M, Richardt G, Laugwitz KL, Neumann FJ, Schunkert H, Schupke S, Kastrati A, Ndrepepa G. Ticagrelor or Prasugrel in Patients With Acute Coronary Syndrome in Relation to Estimated Glomerular Filtration Rate. JACC Cardiovasc Interv. 2021 Sep 13;14(17):1857-1866. doi: 10.1016/j.jcin.2021.06.028. Epub 2021 Aug 23.

    PubMed 34446390

  • Coughlan JJ, Aytekin A, Lahu S, Ndrepepa G, Menichelli M, Mayer K, Wohrle J, Bernlochner I, Gewalt S, Witzenbichler B, Hochholzer W, Sibbing D, Cassese S, Angiolillo DJ, Hemetsberger R, Valina C, Muller A, Kufner S, Liebetrau C, Xhepa E, Hapfelmeier A, Sager HB, Joner M, Fusaro M, Richardt G, Laugwitz KL, Neumann FJ, Schunkert H, Schupke S, Kastrati A. Ticagrelor or Prasugrel for Patients With Acute Coronary Syndrome Treated With Percutaneous Coronary Intervention: A Prespecified Subgroup Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2021 Oct 1;6(10):1121-1129. doi: 10.1001/jamacardio.2021.2228.

    PubMed 34190967

  • Coughlan JJ, Aytekin A, Ndrepepa G, Schupke S, Bernlochner I, Mayer K, Neumann FJ, Menichelli M, Richardt G, Wohrle J, Witzenbichler B, Gewalt S, Xhepa E, Kufner S, Sager HB, Joner M, Ibrahim T, Fusaro M, Laugwitz KL, Schunkert H, Kastrati A, Cassese S. Ticagrelor or Prasugrel in Patients With Acute Coronary Syndrome Undergoing Complex Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2021 Jul;14(7):e010565. doi: 10.1161/CIRCINTERVENTIONS.121.010565. Epub 2021 Jun 16.

    PubMed 34130477

  • Lahu S, Ndrepepa G, Gewalt S, Schupke S, Pellegrini C, Bernlochner I, Aytekin A, Neumann FJ, Menichelli M, Richardt G, Cassese S, Xhepa E, Kufner S, Sager HB, Joner M, Ibrahim T, Fusaro M, Laugwitz KL, Schunkert H, Kastrati A, Mayer K. Efficacy and safety of ticagrelor versus prasugrel in smokers and nonsmokers with acute coronary syndromes. Int J Cardiol. 2021 Sep 1;338:8-13. doi: 10.1016/j.ijcard.2021.06.011. Epub 2021 Jun 11.

    PubMed 34126130

  • Mayer K, Bongiovanni D, Karschin V, Sibbing D, Angiolillo DJ, Schunkert H, Laugwitz KL, Schupke S, Kastrati A, Bernlochner I. Ticagrelor or Prasugrel for Platelet Inhibition in Acute Coronary Syndrome Patients: The ISAR-REACT 5 Trial. J Am Coll Cardiol. 2020 Nov 24;76(21):2569-2571. doi: 10.1016/j.jacc.2020.09.586. No abstract available.

    PubMed 33213734

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ticagrelor and Prasugrel in people with Acute Coronary Syndrome (ACS), run by Deutsches Herzzentrum Muenchen at 19 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Germany, Italy. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 death, myocardial infarction or stroke (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 NCT01944800, which also lists 21 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 6 Feb 2023.

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