Acute Myocardial InfarctionPhase 4REL-0609NCT01636180
Effect of the Repeated Loading Dose of Clopidogrel and High Dose of Clopidogrel Continuous Therapy on the Platelet Aggregation Inhibition in Patients With Myocardial Infarction Undergoing Interventional Treatment.
A Phase 4 study testing Clopidogrel in people with Acute Myocardial Infarction, run by Fundacja Ośrodek Badań Medycznych at 1 site in Poland.
Trial summary
REL-0609 trial's hypothesis is that repeated loading doses of clopidogrel (600 mg) administration in addition to high dose of clopidogrel continuous therapy (150 mg/day) results in higher inhibition of the platelets' aggregation in patients with myocardial infarction undergoing interventional treatment comparing to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 sitePoland
- Study dates
- Mar 2012to May 2015
- 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
Who may be able to join
- •≥18 years of age,
- Myocardial Infarction with or without ST segment elevation,
- clopidogrel treatment (confirmed administration of loading dose of 600 mg or chronic therapy of 75 mg/day),
- signed written informed consent.
Who cannot join
- prior administration of fibrinolytic therapy and/or GP IIb/IIIa inhibitors within the last 14 days,
- prior administration of prasugrel within the last 14 days,
- subject with known hypersensitivity to the active ingredient or other components of the product
- increased risk of bleeding complications:bleeding diathesis, thrombocytopenia (platelet count < 100 000/mm3), oral anticoagulant therapy (INR >1.6), uncontrolled hypertension (systolic blood pressure >200 mmHg), major bleeding, trauma or surgery within the last 30 days,
- acute renal failure,
- acute liver failure,
- pregnancy.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Krakowskie Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii Carint Scanmed Sp. z o.o
Krakow
About this study
REL-0609 trial's hypothesis is that repeated loading doses of clopidogrel (600 mg) administration in addition to high dose of clopidogrel continuous therapy (150 mg/day) results in higher inhibition of the platelets' aggregation in patients with myocardial infarction undergoing interventional treatment comparing to the standard therapy. Such treatment strategy will not cause increased risk of bleeding complications. In many trials treatment with to repeated loading doses of clopidogrel together with high dose of clopidogrel continuous therapy resulted in: MACE reduction, improvement of the long term therapy results, lower risk of ischemic complications. Currently, data regarding to the results of the above treatment are still limited.
Read the detailed description
The objectives of the study is:
- to evaluate the effect of the repeated loading dose of clopidogrel (600 mg) in addition to high dose of clopidogrel continuous therapy (150 mg/day) on the platelet aggregation inhibition in patients with myocardial infarction undergoing interventional treatment
- to evaluate the safety of the repeated loading dose of clopidogrel (600 mg) in addition to high dose of clopidogrel continuous therapy (150 mg/day) in patients with myocardial infarction undergoing interventional treatment
- Conditions
- Acute Myocardial Infarction
- Being tested
- Clopidogrel
- Keywords
- STEMI, NSTEMI, clopidogrel, Areplex, REL-0609
- Medical subject headings
- ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
repeated loading dose of clopidogrel (600 mg) in addition to high dose of clopidogrel continuous therapy for 30 days (150 mg/day)
ClopidogrelDrug
no repeated loading dose of clopidogrel with clopidogrel continuous therapy for 30 days (75 mg/day)
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel - Repeated Loading Dose | Experimental | repeated loading dose of clopidogrel (600 mg) in addition to high dose of clopidogrel continuous therapy for 30 days (150 mg/day) Receives: Drug: Clopidogrel |
| Clopidogrel - standard of care | Active comparator | no repeated loading dose of clopidogrel with clopidogrel continuous therapy for 30 days (75 mg/day) Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
inhibition of platelet aggregation
inhibition of platelet aggregation at the 30-day follow-up visit.
Measured: at 30 days follow-up
inhibition of platelet aggregation
inhibition of platelet aggregation at 1st hour after administration of the repeated loading dose of clopidogrel / placebo
Measured: at 1st hour after administration of the repeated loading dose of clopidogrel / placebo
inhibition of platelet aggregation
inhibition of platelet aggregation at 2nd hour after administration of the repeated loading dose of clopidogrel / placebo
Measured: at 2nd hour after administration of the repeated loading dose of clopidogrel / placebo
inhibition of platelet aggregation
inhibition of platelet aggregation at 6th hour after administration of the repeated loading dose of clopidogrel / placebo
Measured: at 6th hour after administration of the repeated loading dose of clopidogrel / placebo
inhibition of platelet aggregation
inhibition of platelet aggregation at 24th hour after administration of the repeated loading dose of clopidogrel / placebo
Measured: at 24th hour after administration of the repeated loading dose of clopidogrel / placebo
Secondary outcomes (1)
Secondary outcome
frequency of bleeding complications within 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacja Ośrodek Badań Medycznych
- Sponsor type
- University, hospital or other
- Collaborators
- KCRI
- Responsible party
- Sponsor
- Investigators
- Roman Wojdyła, MD, Principal investigator, Krakowskie Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii Carint Scanmed Sp. z o.o
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01636180
- Sponsor's protocol ID
- 1.0, 2009-06-06
- Acronym
- REL-0609
- Status last verified
- Mar 2015
- First submitted
- 5 Apr 2012
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Repeated Loading Dose of Clopidogrel and High Dose of Clopidogrel Continuous Therapy on the Platelet Aggregation Inhibition in Patients With Myocardial Infarction Undergoing Interventional Treatment.
- ClinicalTrials.gov ID
- NCT01636180
- Acronym / sponsor ID
- REL-0609 / 1.0, 2009-06-06
- Conditions
- Acute Myocardial Infarction
- Keywords
- STEMI, NSTEMI, clopidogrel, Areplex, REL-0609
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fundacja Ośrodek Badań MedycznychUniversity, hospital or other
- Collaborators
- KCRI
- Study start
- Mar 2012
- Primary completion
- May 2015 (estimated)
- First posted
- 10 Jul 2012 (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.
REL-0609 trial's hypothesis is that repeated loading doses of clopidogrel (600 mg) administration in addition to high dose of clopidogrel continuous therapy (150 mg/day) results in higher inhibition of the platelets' aggregation in patients with myocardial infarction undergoing interventional treatment comparing to the standard therapy. Such treatment strategy will not cause increased risk of bleeding complications. In many trials treatment with to repeated loading doses of clopidogrel together with high dose of clopidogrel continuous therapy resulted in: MACE reduction, improvement of the long term therapy results, lower risk of ischemic complications. Currently, data regarding to the results of the above treatment are still limited.
Detailed description
The objectives of the study is:
- to evaluate the effect of the repeated loading dose of clopidogrel (600 mg) in addition to high dose of clopidogrel continuous therapy (150 mg/day) on the platelet aggregation inhibition in patients with myocardial infarction undergoing interventional treatment
- to evaluate the safety of the repeated loading dose of clopidogrel (600 mg) in addition to high dose of clopidogrel continuous therapy (150 mg/day) in patients with myocardial infarction undergoing interventional treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel - Repeated Loading Dose | Experimental | Drug: Clopidogrelrepeated loading dose of clopidogrel (600 mg) in addition to high dose of clopidogrel continuous therapy for 30 days (150 mg/day) |
| Clopidogrel - standard of care | Active comparator | Drug: Clopidogrelno repeated loading dose of clopidogrel with clopidogrel continuous therapy for 30 days (75 mg/day) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- •≥18 years of age,
- Myocardial Infarction with or without ST segment elevation,
- clopidogrel treatment (confirmed administration of loading dose of 600 mg or chronic therapy of 75 mg/day),
- signed written informed consent.
Key exclusion criteria (7 listed)
- prior administration of fibrinolytic therapy and/or GP IIb/IIIa inhibitors within the last 14 days,
- prior administration of prasugrel within the last 14 days,
- subject with known hypersensitivity to the active ingredient or other components of the product
- increased risk of bleeding complications:bleeding diathesis, thrombocytopenia (platelet count < 100 000/mm3), oral anticoagulant therapy (INR >1.6), uncontrolled hypertension (systolic blood pressure >200 mmHg), major bleeding, trauma or surgery within the last 30 days,
- acute renal failure,
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 |
|---|---|---|
| Clopidogrelrepeated loading dose of clopidogrel (600 mg) in addition to high dose of clopidogrel continuous therapy for 30 days (150 mg/day) | Drug | Clopidogrel - Repeated Loading Dose |
| Clopidogrelno repeated loading dose of clopidogrel with clopidogrel continuous therapy for 30 days (75 mg/day) | Drug | Clopidogrel - standard of care |
Primary outcome
inhibition of platelet aggregation
Time frame: at 30 days follow-up
inhibition of platelet aggregation at the 30-day follow-up visit.
inhibition of platelet aggregation
Time frame: at 1st hour after administration of the repeated loading dose of clopidogrel / placebo
inhibition of platelet aggregation at 1st hour after administration of the repeated loading dose of clopidogrel / placebo
inhibition of platelet aggregation
Time frame: at 2nd hour after administration of the repeated loading dose of clopidogrel / placebo
inhibition of platelet aggregation at 2nd hour after administration of the repeated loading dose of clopidogrel / placebo
inhibition of platelet aggregation
Time frame: at 6th hour after administration of the repeated loading dose of clopidogrel / placebo
inhibition of platelet aggregation at 6th hour after administration of the repeated loading dose of clopidogrel / placebo
inhibition of platelet aggregation
Time frame: at 24th hour after administration of the repeated loading dose of clopidogrel / placebo
inhibition of platelet aggregation at 24th hour after administration of the repeated loading dose of clopidogrel / placebo
1 secondary outcome
Secondary outcome
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
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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.
Roman Wojdyła, MD principal investigator
Krakowskie Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii Carint Scanmed Sp. z o.o
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clopidogrel in people with Acute Myocardial Infarction, run by Fundacja Ośrodek Badań Medycznych at 1 site in Poland.
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 7 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: withdrawn, as of the sponsor's last update on 6 Mar 2015. 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 Poland. 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 was withdrawn before enrolling participants, so there are no results.
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?
inhibition of platelet aggregation (time frame: at 30 days follow-up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2015.