A Phase 4 interventional study of Clopidogrel in Ischemic Stroke, sponsored by Zealand University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-28.
Sponsored by Zealand University Hospital · Phase 4, Interventional, and Prevention
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Among 18 studies testing clopidogrel in Ischemic Stroke — 5 open to participants now, 5 under way, 3 of them phase 3. Clopidogrel · Ischemic Stroke.
Among the 18 studies testing clopidogrel in Ischemic Stroke, this one is the 16th largest by enrollment, is one of 2 that started in 2015, is one of 7 in phase 4, and was the 6th registered.
2,617 studies on the registry are indexed under Ischemic Stroke; 976 are open to participants now.
Browse Ischemic Stroke studies →5 of the 18 studies testing clopidogrel in Ischemic Stroke are open now, in 2 countries. Recruiting first, the newest first:
Kafrelsheikh University · Sites in Egypt
Ages 18–75
Kafrelsheikh University · Sites in Egypt
Ages 18–75
Kafrelsheikh University · Sites in Egypt
Ages 18–75
Sichuan Provincial People's Hospital · Sites in China
Ages 18+
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Sites in China
Ages 40–80
By country, each count listing its studies:
Clopidogrel: first FDA approval 1997 (PLAVIX), first EMA approval 1998. What it is approved for, and how studies give it, is on its page →
Of the 661 Ischemic Stroke studies recruiting now, 396 (60%) set no upper age limit and 62 (9%) stop at 75 or younger; 26 take children under 18; 42 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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18 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 2 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 103 is below the median of 120 across 1,780 interventional studies indexed under Ischemic Stroke.
Median enrollment 725 across the 18 interventional studies. Of the 12 that completed or were terminated, 0 (0%) have results posted.
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None of the 18 has an industry lead sponsor. The 9 most frequent:
Zealand University Hospital is the lead sponsor of 236 studies on the registry; 50 are open to participants now.
Zealand University Hospital has 3 studies filed under Ischemic Stroke — fewer than ten, so there is no comparison to draw.
1 of the studies testing clopidogrel in Ischemic Stroke that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05910125Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityAspirin Combined With Clopidogrel Versus Intravenous Alteplase for Acute Minor Stroke | 2027-07 |
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Among the 18 studies testing clopidogrel in Ischemic Stroke, from their registry updates:
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Personalized therapy as prophylaxis in ischemic stroke patients is not yet an option. From patients with ischemic heart disease, we know that patients with in vitro high on treatment platelet reactivity (HTPR) have an increased risk of stent thrombosis following per-cutaneous coronary intervention. Other studies have shown association of CYP2C19 genotypes with different responses to the anti platelet drug Clopidogrel. We measure HTPR in ischemic stroke patients on increasing doses of clopidogrel and investigate the CYP2C19 genotype for each patient.
Background: Clopidogrel (CLO) is a pro-drug metabolized in the liver by the Cytochrom-P450 system to its active component. Studies in acute ischemic stroke (IS) patients have proven that genetic differences in coding of an enzyme responsible for the metabolism of CLO (CYP2C19) results in different response to CLO when tested in the blood. An American study in cardiac patients have shown an association between the genotype and the CLO-response to different dosages of CLO, meaning that patients who are non-responders to low dosages of CLO may be responders to higher CLO dosages. Furthermore, the study showed that patients with a distinct genotype does not gain CLO response even at high CLO dosages (300 mg/day).
Perspective: The study will have an impact on the patient, the relatives and the social economy. The project answers if it is possible to give personalized therapy to IS patients securing the best possible prophylactic treatment for each single patient. Hereby reducing the risk of early death, disability and dependency. The project determines the genetic distribution of CYP2C19 alleles in the Danish IS population and determine the association between genotype and CLO-response in clinically relevant dosages in a Caucasian population of IS patients.
Objective: To determine the correlation between genotype and Clopidogrel response to different CLO dosage and to determine the distribution of different alleles of CYP2C19 genotypes in a Danish IS population.
Hypothesis: CLO response is determined by CYP2C19 genotype, and there is a correlation between drug-response and CYP2C19 genotype.
Method: Systematic recording of data on 103 IS patients receiving prophylactic treatment with CLO 75 mg/day.
Genotype is determined in collaboration with Division of Clinical Biochemistry, Dept. of Diagnostics, Glostrup Hospital determining the CYP2C19 genotype *1(wild-type), *2(Loss Of Function=LOF) and *17(Gain Of Function=GOF). CLO responder status is determined using the VerifyNow P2Y12 assays.
Patients receiving CLO 75 mg/day who are non-responders when testing with VerifyNow P2Y12 assays have a blood sample for genetic testing. Patients carrying the *2 genotype on one or both alleles are CLO responder status tested on increasing doses of CLO, rising 75 mg/day every 14 days (150/225/300 mg) until maximum CLO 300 mg/day. Responder status is tested at the end of every second week, before increasing dosage. If the patient is CLO responder on the tested dose (150/225/300 mg) or non-responder on CLO 300 mg/day, the patient is ended in the study and switched to treatment with ASA in combination with Dipyramidole.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Increasing doses og Clopidogrel depending on PRU values measured on VerifyNow
Drug: Clopidogrel
increasing doses of clopidogrel depending on PRU values (75-300 mg)
Number of patients who has clopidogrel HTPR
Clopidogrel responder status measured with VerifyNow
Time frame: 7 days
Number of patients who are carriers of CYP2C19 loss-of-function alleles
Genotyping patients for different loss-of-function CYP2C19 alleeles (\*2, \*3)
Time frame: 1 day
Number of patients who are carriers of P2Y12-receptor loss-of-function alleles
genotyping patients for different loss-of-function P2Y12 receptor alleeles
Time frame: 1 day
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2015 to primary completion in Jul 2017, 20 months.
Of 76 non-industry phase 4 interventional studies under Ischemic Stroke, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 42. This study's 20 months is below that.
Counting every sponsor, half of 85 studies reached it within 31 months; a quarter within 24 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Clopidogrel