Coronary Heart DiseasePhase 4ISAR ADAPT PFNCT01456364
Intracoronary Stenting and Antithrombotic Regimen: ADjusting Antiplatelet Treatment in PatienTs Based on Platelet Function Testing
A Phase 4 study testing Ticagrelor and Prasugrel in people with Coronary Heart Disease, run by Deutsches Herzzentrum Muenchen at 3 sites in 2 countries.
Trial summary
Clopidogrel low response is associated with a significantly higher risk for ischemic complications after percutaneous coronary intervention. Ticagrelor and prasugrel are more potent platelet inhibitory drugs and both have been shown to significantly reduce ischemic events as compared to clopidogrel. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Ticagrelor and Prasugrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Sep 2011to May 2014
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- successful PCI
- 600 mg clopidogrel pretreatment
- clopidogrel low response assessed with electrode aggregometry (>= 486 AU*min)
- written informed consent
Who cannot join
- Contraindications or allergies against study drugs
- Anemia
- Any surgery < 6 weeks
- Increased bleeding risk
- Oral anticoagulation
- platelet count < 100.000/µl
Show all 17Show fewer
- Prior history of stroke or pathologic intracranial findings
- GPIIb/IIIa antagonists < 10 days or periprocedural
- Age > 80 years, < 18 years
- Body weight < 60 kg
- Cardiogenic shock
- Increased risk of bradycardia
- Moderate liver disease
- Kidney dialysis
- Intake of CYP 3A4 inhibitors
- Pregnancy or lactation
- Missing pregnancy test for women capable of bearing children
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites, 2 recruiting
- Recruiting
Deutsches Herzzentrum
München, Bavaria, 80636
Katharina Mayer, MD, +49-89-1218-2020, mayer.katharina@dhm.mhn.de
Isabell Bernlochner, MD, +49-89-4140-0, isabell.bernlochner@gmx.de
- Recruiting
Klinikum der Ludwig-Maximilians-Universität München
München, Bavaria, 81377
Martin Orban, MD, +49 89 7095 2371, martin.Orban@med.uni-muenchen.de
Dirk Sibbing, MD, +49 89 5160 2215, Dirk.Sibbing@med.uni-muenchen.de
Hungary1 site, 1 recruiting
- Not yet recruiting
Heart Center Balatonfüred, Dept. of Cardiology
Balatonfüred, 8230
Daniel Aradi, MD, +36302355639, daniel_aradi@yahoo.com
Daniel Aradi, MD
About this study
Official title: Prospective, Randomized Study of the Platelet Inhibitory Efficacy of Ticagrelor Versus Prasugrel in Clopidogrel Low Responders After Percutaneous Coronary Intervention
Clopidogrel low response is associated with a significantly higher risk for ischemic complications after percutaneous coronary intervention. Ticagrelor and prasugrel are more potent platelet inhibitory drugs and both have been shown to significantly reduce ischemic events as compared to clopidogrel. No direct comparison between ticagrelor and prasugrel in terms of their antiplatelet efficacy exists. The aim of this study is to assess the antiplatelet treatment efficacy of ticagrelor versus prasugrel over time in confirmed clopidogrel low responders undergoing percutaneous coronary intervention.
- Conditions
- Coronary Heart Disease
- Being tested
- Ticagrelor, Prasugrel
- Keywords
- clopidogrel low response, ticagrelor, prasugrel, platelet aggregation
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
A loading dose of 180 mg of ticagrelor is administered followed by 90 mg maintenance doses twice daily
PrasugrelDrug
A prasugrel loading dose of 60 mg is administered followed by a 10 mg per day maintenance dose for patients < 75 years or a 5 mg maintenance dose per day for patients >= 75 years
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor | Active comparator | A loading dose of 180 mg of ticagrelor is administered followed by 90 mg maintenance doses twice daily Receives: Drug: Ticagrelor |
| Prasugrel | Active comparator | A prasugrel loading dose of 60 mg is administered followed by a 10 mg per day maintenance dose for patients < 75 years or a 5 mg maintenance dose per day for patients >= 75 years Receives: Drug: Prasugrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADP-induced platelet aggregation after randomized treatment with ticagrelor or prasugrel
Measured: Day 2 post randomization
Secondary outcomes (2)
Proportion of low responders in ticagrelor or prasugrel group
Low platelet response is defined as platelet aggregation values >=468 AU*min
Measured: Day 2 post randomization
Proportion of enhanced responders in ticagrelor or prasugrel group
Enhanced platelet response is defined as platelet aggregation values <= 188 AU*min
Measured: Day 2 post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionApr 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katharina Mayer, MD, Principal investigator, Deutsches Herzzentrum MünchenMartin Orban, MD, Principal investigator, Klinikum der Ludwig-Maximilian-Universität München, Campus GroßhadernDaniel Aradi, MD, Principal investigator, Heart Center Balatonfüred, Dept. of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456364
- Sponsor's protocol ID
- GE-DHM A01811
- Acronym
- ISAR ADAPT PF
- Status last verified
- Oct 2013
- First submitted
- 18 Oct 2011
- Last updated
- 1 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sibbing D, Braun S, Morath T, Mehilli J, Vogt W, Schomig A, Kastrati A, von Beckerath N. Platelet reactivity after clopidogrel treatment assessed with point-of-care analysis and early drug-eluting stent thrombosis. J Am Coll Cardiol. 2009 Mar 10;53(10):849-56. doi: 10.1016/j.jacc.2008.11.030.
PubMed 19264241Wiviott SD, Braunwald E, McCabe CH, Montalescot G, Ruzyllo W, Gottlieb S, Neumann FJ, Ardissino D, De Servi S, Murphy SA, Riesmeyer J, Weerakkody G, Gibson CM, Antman EM; TRITON-TIMI 38 Investigators. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2007 Nov 15;357(20):2001-15. doi: 10.1056/NEJMoa0706482. Epub 2007 Nov 4.
PubMed 17982182Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators; Freij A, Thorsen M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.
PubMed 19717846
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Study of the Platelet Inhibitory Efficacy of Ticagrelor Versus Prasugrel in Clopidogrel Low Responders After Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT01456364
- Acronym / sponsor ID
- ISAR ADAPT PF / GE-DHM A01811
- Conditions
- Coronary Heart Disease
- Keywords
- clopidogrel low response, ticagrelor, prasugrel, platelet aggregation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Apr 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 20 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clopidogrel low response is associated with a significantly higher risk for ischemic complications after percutaneous coronary intervention. Ticagrelor and prasugrel are more potent platelet inhibitory drugs and both have been shown to significantly reduce ischemic events as compared to clopidogrel. No direct comparison between ticagrelor and prasugrel in terms of their antiplatelet efficacy exists. The aim of this study is to assess the antiplatelet treatment efficacy of ticagrelor versus prasugrel over time in confirmed clopidogrel low responders undergoing percutaneous coronary intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor | Active comparator | Drug: TicagrelorA loading dose of 180 mg of ticagrelor is administered followed by 90 mg maintenance doses twice daily |
| Prasugrel | Active comparator | Drug: PrasugrelA prasugrel loading dose of 60 mg is administered followed by a 10 mg per day maintenance dose for patients < 75 years or a 5 mg maintenance dose per day for patients >= 75 years |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- successful PCI
- 600 mg clopidogrel pretreatment
- clopidogrel low response assessed with electrode aggregometry (>= 486 AU*min)
- written informed consent
Key exclusion criteria (17 listed)
- Contraindications or allergies against study drugs
- Anemia
- Any surgery < 6 weeks
- Increased bleeding risk
- Oral anticoagulation
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 |
|---|---|---|
| TicagrelorA loading dose of 180 mg of ticagrelor is administered followed by 90 mg maintenance doses twice daily | Drug | Ticagrelor |
| PrasugrelA prasugrel loading dose of 60 mg is administered followed by a 10 mg per day maintenance dose for patients < 75 years or a 5 mg maintenance dose per day for patients >= 75 years | Drug | Prasugrel |
Primary outcome
ADP-induced platelet aggregation after randomized treatment with ticagrelor or prasugrel
Time frame: Day 2 post randomization
2 secondary outcomes
Proportion of low responders in ticagrelor or prasugrel group
Time frame: Day 2 post randomization
Proportion of enhanced responders in ticagrelor or prasugrel group
Time frame: Day 2 post randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2013.
- Background: PubMed 19264241Sibbing D, Braun S, Morath T, Mehilli J, Vogt W, Schomig A, Kastrati A, von Beckerath N. Platelet reactivity after clopidogrel treatment assessed with point-of-care analysis and early drug-eluting stent thrombosis. J Am Coll Cardiol. 2009 Mar 10;53(10):849-56. doi: 10.1016/j.jacc.2008.11.030.
- Background: PubMed 17982182Wiviott SD, Braunwald E, McCabe CH, Montalescot G, Ruzyllo W, Gottlieb S, Neumann FJ, Ardissino D, De Servi S, Murphy SA, Riesmeyer J, Weerakkody G, Gibson CM, Antman EM; TRITON-TIMI 38 Investigators. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2007 Nov 15;357(20):2001-15. doi: 10.1056/NEJMoa0706482. Epub 2007 Nov 4.
- Background: PubMed 19717846Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators; Freij A, Thorsen M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.
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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.
Katharina Mayer, MD principal investigator
Deutsches Herzzentrum München
Martin Orban, MD principal investigator
Klinikum der Ludwig-Maximilian-Universität München, Campus Großhadern
Daniel Aradi, MD principal investigator
Heart Center Balatonfüred, Dept. of Cardiology
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ticagrelor and Prasugrel in people with Coronary Heart Disease, run by Deutsches Herzzentrum Muenchen at 3 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?
The sponsor lists 4 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Hungary. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katharina Mayer, MD (+49-89-1218-2020, mayer.katharina@dhm.mhn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADP-induced platelet aggregation after randomized treatment with ticagrelor or prasugrel (time frame: Day 2 post randomization). 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 NCT01456364, 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 1 Nov 2013.