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Acute Coronary SyndromePhase 3TROUPERNCT03357874

TicagRelor Or Clopidogrel in Severe and Terminal Chronic Kidney Disease Patients Undergoing PERcutaneous Coronary Intervention for an Acute Coronary Syndrome.

A Phase 3 study testing Clopidogrel and Ticagrelor in people with Acute Coronary Syndrome, run by Assistance Publique Hopitaux De Marseille 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

Ticagrelor is a potent and fast-acting P2Y12-ADP receptor antagonist recommended as first-line agent in ACS (2). This drug was associated with a 20% relative reduction in the rate of MACE in ACS patients undergoing PCI compared to clopidogrel. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
Clopidogrel and Ticagrelor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
259 participants
Where
1 siteFrance
Study dates
28 Oct 2018to 18 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

  • Must not be of child-bearing potential (1 year post-menopausal, contraceptive or surgically sterile).
  • non-ST-segment elevation ACS defined by the presence of at least 2 of the following criteria: (1) symptoms of myocardial ischemia, (2) electrocardiographic ST-segment abnormalities (depression or transient elevation of at least 0.1 mV) or T-wave inversion in at least in 2 contiguous leads, or (3) an elevated cardiac troponin value (above the upper limit of normal) (2) or ST segment elevation ACS scheduled for primary PCI defined (22)as a history of chest discomfort or ischemic symptoms of >20 minutes duration at rest ≤14 days prior to entry into the study with one of the following present on at least one ECG prior to randomization:
  • ST-segment elevation ≥1 mm in two or more contiguous ECG leads.
  • New or presumably new left bundle branch block (LBBB).
  • ST-segment depression ≥1 mm in two anterior precordial leads (V1 through V4) with clinical history and evidence suggestive of true posterior infarction
  • Subject intended for an invasive strategy if NSTE-ACS or primary PCI if STE-ACS according to guidelines (annexe 1)
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  • Subject CKD stage 4 and 5 (estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m2 by (MDRD formula) or undergoing chronic dialysis
  • Must be enrolled at a cardiac catheterization laboratory hospital or at a hospital/ambulance service affiliated with a cardiac catheterization laboratory hospital.
  • Subject affiliated to or beneficiary of a social security system.
  • Subject having signed written informed consent.

Who cannot join

  • Minors, pregnant or breast-feeding women;
  • Subject under chronic anticoagulant
  • Subject with thrombolytic therapy during the preceding 24 hours;
  • Subject with bleeding ;
  • Subject participating in another research protocol;
  • Subject not agreeing to participate.
Show all 14Show fewer
  • Subject with contraindication to clopidogrel or ticagrelor
  • Severe hepatic failure
  • Ischemic Stroke within one month or a history of hemorrhagic stroke
  • Bradycardia
  • Platelet count<100 000
  • Major surgery or trauma within 10 days
  • Life expectancy <1 year
  • Known significant bleeding risk according to the physician judgment

Trial locations and contacts

1 site in 1 country.

France1 site

  • APHM

    Marseille, 13354

Other trials in France

About this study

Ticagrelor is a potent and fast-acting P2Y12-ADP receptor antagonist recommended as first-line agent in ACS (2). This drug was associated with a 20% relative reduction in the rate of MACE in ACS patients undergoing PCI compared to clopidogrel. This benefit came without any increase in major bleedings compared to clopidogrel (6).

In the PLATO trial, a limited number of kidney failure patients were included (21%) and patients with terminal CKD were excluded. A sub-group analysis focused on CKD patients was performed. Only 214 patients with CKD below stage 4 (creatinine clearance <30 ml/min) were included (7). No patient with terminal CKD or undergoing chronic hemodialysis was included.

Read more

Of importance, kidney function impairment is frequent and affects up-to 40 % of ACS patients. In addition, CKD is a powerful independent predictor of ischemic complications during ACS (8-9).Indeed, CKD patients have a very high risk of MACE following ACS with an odd ratio between 2 and 3 compared to patients with normal kidney function and event rates above 40% at one year follow-up (8-13). Of importance these patients more often have high on-clopidogrel platelet reactivity which was strongly associated with a worse clinical outcome (3,14-16). In CKD patients HTPR was associated with death after PCI (15). Accordingly ticagrelor which overcomes these limitations of clopidogrel could be associated with a major clinical benefit in severe or terminal CKD patients.

Most of ticagrelor and is active metabolites are excreted through the feces. Preclinical data suggested that renal impairment had little effect on systemic exposure to the drug(EMEA/H/C/1241 (28)). Recent pharmacodynamic and kinetic studies confirmed these preclinical data on the safety of ticagrelor in severe and end-stage CKD (17-19).

Therefore based on the rational above and to the lack of relevant clinical data, the optimal P2Y12-ADP receptor antagonist for patients with stage 4 and 5 and patients undergoing chronic dialysis remains undetermined in ACS treated with PCI.

We aimed to compare the clinical efficacy ticagrelor and clopidogrel in patients with stage 4 and 5 or on chronic hemodialysis undergoing PCI for ACS.

Being tested
Clopidogrel, Ticagrelor
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.

  • ClopidogrelDrug

    600 mg loading dose of clopidogrel as pretreatment followed by 75 mg daily for 12 months (52 weeks).

  • TicagrelorDrug

    patients will receive a 180 mg loading dose as pretreatment of PCI followed by 90 mg bi-daily for 12 months (52 weeks).

Study groups in NCT03357874
Study groupRoleWhat they receive
Clopidogrel groupExperimentalNot described
Receives: Drug: Clopidogrel
Ticagrelor groupExperimentalNot described
Receives: Drug: Ticagrelor

What is being measured

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

  1. the rate of major adverse cardiovascular events

    Measured: 12 MONTHS

Secondary outcomes (7)

  1. the rate of bleedings

    using the Bleeding Academic Research Consortium classification ≥3 defined at discharge

    Measured: 1 MONTH AND 12MONTHS

  2. the rate of myocardial infarction at discharge

    Measured: 1 MONTH AND 12MONTHS

  3. the rate of cardiovascular death at discharge

    Measured: 1MONTH AND 12 MONTHS

  4. the rate of urgent revascularization at discharge

    Measured: 1MONTH AND 12 MONTHS

  5. the rate of all-cause death at discharge

    Measured: 1MONTH AND 12 MONTHS

  6. the rate of hospital re-admission

    Measured: 1MONTH AND 12 MONTHS

  7. the rate of probable and definite stent thrombosis (ARC definition) at discharge

    Measured: 1MONTH AND 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 posted30 Nov 2017
  2. Study start28 Oct 2018
  3. Primary completion1 Jan 2023
  4. Study completion18 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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
259 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03357874
Sponsor's protocol ID
2017-41
Other IDs
2017-002839-42, 2017
Acronym
TROUPER
Status last verified
Jun 2025
First submitted
14 Nov 2017
Last updated
27 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.

    PubMed 35224730

  • Laine M, Lemesle G, Burtey S, Cayla G, Range G, Quaino G, Canault M, Pankert M, Paganelli F, Puymirat E, Bonello L. TicagRelor Or Clopidogrel in severe or terminal chronic kidney patients Undergoing PERcutaneous coronary intervention for acute coronary syndrome: The TROUPER trial. Am Heart J. 2020 Jul;225:19-26. doi: 10.1016/j.ahj.2020.04.013. Epub 2020 Apr 30.

    PubMed 32473355

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Clopidogrel and Ticagrelor in people with Acute Coronary Syndrome, run by Assistance Publique Hopitaux De Marseille 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 10 inclusion and 14 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 27 Jun 2025. 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?

the rate of major adverse cardiovascular events (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 NCT03357874, which also lists 2 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 27 Jun 2025.

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