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GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by ECRI bv
Sponsor:
Collaborators:
Biosensors International
AstraZeneca
The Medicines Company
Information provided by (Responsible Party):
ECRI bv
ClinicalTrials.gov Identifier:
NCT01813435
First received: February 12, 2013
Last updated: October 29, 2014
Last verified: September 2014
  Purpose

After a stent procedure, it is common practice to prescribe anti-platelet medication to prevent the blood from clotting. The main objective of this study is to determine if there is a better medication strategy to prevent blood from clotting and at the same time minimising the number of complications.

There are two medication strategies:

  • Study group: Dual anti-platelet therapy (ticagrelor combined with aspirin) for 1 month, and then ticagrelor alone for another 23 months OR
  • Control group: Standard treatment, being dual anti-platelet therapy (ticagrelor or clopidogrel combined with aspirin) for 12 months, and then aspirin alone indefinitely

Condition Intervention Phase
Coronary Artery Disease (CAD)
Drug: Ticagrelor
Drug: Acetylsalicylic Acid
Drug: Clopidogrel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative Effectiveness of 1 Month of Ticagrelor Plus Aspirin Followed by Ticagrelor Monotherapy Versus a Current-day Intensive Dual Antiplatelet Therapy in All-comers Patients Undergoing Percutaneous Coronary Intervention With Bivalirudin and BioMatrix Family Drug-eluting Stent Use

Resource links provided by NLM:


Further study details as provided by ECRI bv:

Primary Outcome Measures:
  • Composite of all-cause mortality or non-fatal new Q-wave MI [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
    The composite of all-cause mortality or non-fatal new Q-wave MI up to 2 years post randomisation.


Secondary Outcome Measures:
  • Bleeding [ Time Frame: 2-year ] [ Designated as safety issue: Yes ]
    The composite of investigator-reported BARC3 or BARC5 bleeding according to BARC definitions up to 2 years post randomisation.


Other Outcome Measures:
  • Additional Endpoints [ Time Frame: 2-year ] [ Designated as safety issue: Yes ]
    All-cause mortality

  • Additional Endpoints [ Time Frame: 2-year ] [ Designated as safety issue: Yes ]
    Non-fatal new Q-wave MI

  • Additional Endpoint [ Time Frame: 2-year ] [ Designated as safety issue: Yes ]
    Ischemic stroke, including stroke of undetermined cause

  • Additional Endpoint [ Time Frame: 2-year ] [ Designated as safety issue: Yes ]
    Haemorrhagic stroke

  • Additional Endpoint [ Time Frame: 2-year ] [ Designated as safety issue: Yes ]
    Composite of all-cause mortality, stroke and non-fatal new Q-wave MI

  • Additional Endpoints [ Time Frame: 2-year ] [ Designated as safety issue: Yes ]
    Coronary revascularisation

  • Additional Endpoint [ Time Frame: 2-year ] [ Designated as safety issue: Yes ]
    Definite Stent Thrombosis according to the Academic Research Consortium


Estimated Enrollment: 16000
Study Start Date: May 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental treatment strategy

All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.

Dosage and frequency:

Ticagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)

Drug: Ticagrelor
Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.
Other Name: Brilique
Drug: Acetylsalicylic Acid
Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy
Other Names:
  • Aspirin
  • B01AC06
Active Comparator: Reference treatment strategy

Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.

Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.

Dosage and frequency:

Brilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd

Drug: Ticagrelor
Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.
Other Name: Brilique
Drug: Acetylsalicylic Acid
Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy
Other Names:
  • Aspirin
  • B01AC06
Drug: Clopidogrel

Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.

Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy

Other Names:
  • Plavix
  • B01AC04

Detailed Description:

The study objective is to determine in all-comers patients undergoing PCI under standardised treatment (including the BioMatrix family of drug-eluting stents and bivalirudin), whether treatment with 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy is superior with respect to the composite of all-cause mortality or non-fatal new Q-wave MI compared to treatment with 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.

The study design is an investigator-initiated, prospective randomised, multi-centre, multi-national, open-label trial to be conducted in approximately 60-80 interventional cardiology centres in Europe, North America, South America and Asia-Pacific. Patients will be randomised at a 1:1 ratio to study or reference treatment strategy.

Randomisation will occur at the time of the index procedure prior to PCI. Subjects will be stratified according to centre and according to the clinical presentation (Stable Coronary Artery Disease (CAD) vs. Acute Coronary Syndrome (ACS)).

All patients will be followed for a period of 2 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-"All comer" patients

  1. Age ≥18 years;
  2. Presence of one or more coronary artery stenoses of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation. The vessel should have a reference vessel diameter of at least 2.25 mm (no limitation on the number of treated lesions, vessels, or lesion length);
  3. Able to provide informed consent and willing to participate in 2 year follow- up period.

Exclusion Criteria:

  1. Known intolerance to aspirin, P2Y12 inhibitors, bivalirudin, stainless steel or biolimus;
  2. Known intake of a strong CYP3A4 inhibitor (e.g., ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir), as co-administration may lead to a substantial increase in exposure to ticagrelor;
  3. Known moderate to severe hepatic impairment (alanine-aminotransferase ≥ 3 x ULN);
  4. Planned surgery, including CABG as a staged procedure (hybrid) within 12 months of the index procedure, unless dual antiplatelet therapy is maintained throughout the peri-surgical period;
  5. Need for chronic oral anti-coagulation therapy;
  6. Active major bleeding or major surgery within the last 30 days;
  7. Known history of intracranial haemorrhagic stroke or intra-cranial aneurysm;
  8. Known stroke (any type) within the last 30 days;
  9. Known pregnancy at time of randomisation;
  10. Female who is breastfeeding at time of randomisation;
  11. Currently participating in another trial and not yet at its primary endpoint.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01813435

Contacts
Contact: Janette Symons JSymons@cardialysis.nl
Contact: Linda Korthout lkorthout@cardialysis.nl

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Locations
Australia
Research centre Box Hill, 6106 Not yet recruiting
Box Hill, Australia
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Research centre Brisbane, 6101 Not yet recruiting
Brisbane, Australia
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Research centre Melbourne, 6104 Not yet recruiting
Melbourne, Australia
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Research centre Melbourne, 6105 Not yet recruiting
Melbourne, Australia
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Research centre Perth, 6102 Not yet recruiting
Perth, Australia
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Research centre Sydney, 6103 Not yet recruiting
Sydney, Australia
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Austria
Research centre Graz, 4305 Recruiting
Graz, Austria
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Rsearch centre Innsbruck, 4303 Recruiting
Innsbruck, Austria
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Research centre Linz, 4304 Recruiting
Linz, Austria
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Research centre Vienna, 4301 Recruiting
Vienna, Austria
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Research centre Vienna, 4302 Recruiting
Vienna, Austria
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Belgium
Research centre Aalst, 3201 Active, not recruiting
Aalst, Belgium
Research centre Aalst, 3206 Recruiting
Aalst, Belgium
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Research centre Bonheiden, 3204 Recruiting
Bonheiden, Belgium
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Research centre Charleroi, 3202 Recruiting
Charleroi, Belgium
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Research centre Genk, 3205 Recruiting
Genk, Belgium
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Research centre Hasselt, 3203 Recruiting
Hasselt, Belgium
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Brazil
Research centre Rio de Janeiro, 5503 Not yet recruiting
Rio de Janeiro, Brazil
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Research centre Rio de Janeiro, 5504 Not yet recruiting
Rio de Janeiro, Brazil
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Sao Paulo, Brazil
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Sao Paulo, Brazil
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Research centre Uberlândia, 5505 Not yet recruiting
Uberlândia, Brazil
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Bulgaria
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Burgas, Bulgaria
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Research centre Plovdiv, 9905 Not yet recruiting
Plovdiv, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Research centre Varna, 9906 Not yet recruiting
Varna, Bulgaria
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Canada
Research centre Newmarket, 1003 Recruiting
Newmarket, Canada
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Research centre Quebec, 1001 Not yet recruiting
Quebec, Canada
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Denmark
Research centre Copenhagen, 4501 Recruiting
Copenhagen, Denmark
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Research centre Roskilde, 4503 Recruiting
Roskilde, Denmark
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France
Research centre Aix en Provence, 3311 Not yet recruiting
Aix en Provence, France
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Research centre Caen, 3308 Not yet recruiting
Caen, France
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Research centre Caen, 3309 Recruiting
Caen, France
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Research centre Clermont-Ferrand, 3303 Not yet recruiting
Clermont-Ferrand, France
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Research centre Dijon, 3313 Not yet recruiting
Dijon, France
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Research centre Grenoble, 3312 Not yet recruiting
Grenoble Cedex, France
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Research centre Lyon, 3316 Not yet recruiting
Lyon, France
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Research centre Nancy, 3314 Not yet recruiting
Nancy, France
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Research centre Paris, 3301 Recruiting
Paris, France
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Research centre Paris, 3305 Recruiting
Paris / Creteil, France
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Research centre Rouen, 3307 Not yet recruiting
Rouen, France
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Research centre Saint Etienne, 3310 Not yet recruiting
Saint Etienne, France
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Research centre Toulouse, 3302 Recruiting
Toulouse, France
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Germany
Research centre Bad Krozingen, 4904 Recruiting
Bad Krozingen, Germany
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Research centre Bad Nauheim, 4902 Recruiting
Bad Nauheim, Germany
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Research centre Berlin, 4918 Not yet recruiting
Berlin, Germany
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Research centre Bonn, 4911 Recruiting
Bonn, Germany
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Research centre Dresden, 4908 Recruiting
Dresden, Germany
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Research centre Essen, 4903 Recruiting
Essen, Germany
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Research centre Fulda, 4905 Recruiting
Fulda, Germany
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Research centre Giessen 4901 Recruiting
Giessen, Germany
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Research centre Göttingen, 4907 Recruiting
Göttingen, Germany
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Research centre Landshut, 4909 Recruiting
Landshut, Germany
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Research centre Lubeck, 4917 Not yet recruiting
Lubeck, Germany
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Research centre Mainz, 4910 Recruiting
Mainz, Germany
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Research centre Mannheim, 4912 Recruiting
Mannheim, Germany
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Research centre Mönchengladbach, 4915 Not yet recruiting
Mönchengladbach, Germany
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Research centre Neuss, 4916 Not yet recruiting
Neuss, Germany
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Research centre Tubingen, 4914 Recruiting
Tubingen, Germany
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Research centre Villingen - Schwenningen, 4919 Not yet recruiting
Villingen - Schwenningen, Germany
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Hungary
Research centre Balatonfüred, 3608 Recruiting
Balatonfüred, Hungary
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Research centre Budapest, 3603 Not yet recruiting
Budapest, Hungary
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Budapest, Hungary
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Research centre Debrecen, 3607 Recruiting
Debrecen, Hungary
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Research centre Gyula, 3606 Recruiting
Gyula, Hungary
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Research centre Nyíregyháza, 3605 Recruiting
Nyíregyháza, Hungary
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Research centre Pécs, 3604 Not yet recruiting
Pécs, Hungary
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Research centre szeged, 3601 Recruiting
Szeged, Hungary
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Italy
Research centre Arezzo, 3902 Recruiting
Arezzo, Italy
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Research centre Brescia, 3912 Not yet recruiting
Brescia, Italy
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Research centre Ferrara, 3905 Recruiting
Ferrara, Italy
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Research centre Mercogliano, 3904 Not yet recruiting
Mercogliano, Italy
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Research centre Milano, 3901 Recruiting
Milano, Italy
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Research centre Pavia, 3903 Recruiting
Pavia, Italy
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Research centre Terni, 3909 Recruiting
Terni, Italy
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Netherlands
Research centre Alkmaar, 3106 Recruiting
Alkmaar, Netherlands
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Research centre Amsterdam, 3104 Recruiting
Amsterdam, Netherlands
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Research centre Groningen, 3108 Recruiting
Groningen, Netherlands
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Research centre Leeuwarden, 3102 Active, not recruiting
Leeuwarden, Netherlands
Research centre Nieuwegein, 3107 Recruiting
Nieuwegein, Netherlands
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Research centre Nijmegen, 3105 Active, not recruiting
Nijmegen, Netherlands
Research centre Rotterdam, 3101 Active, not recruiting
Rotterdam, Netherlands
Research centre Rotterdam, 3103 Recruiting
Rotterdam, Netherlands
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Research centre Tilburg, 3109 Recruiting
Tilburg, Netherlands
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Poland
Research centre Chrzanow, 4802 Recruiting
Chrzanow, Poland
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Research centre Dabrowa Gornicza, 4801 Recruiting
Dabrowa Gornicza, Poland
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Research centre Kedzierzyn-Kozle, 4805 Recruiting
Kedzierzyn-Kozle, Poland
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Research centre Krakov, 4807 Recruiting
Krakov, Poland
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Research centre Mielec, 4809 Recruiting
Mielec, Poland
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Research centre Nysa, 4808 Recruiting
Nysa, Poland
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Research centre Ustroń, 4803 Recruiting
Ustroń, Poland
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Portugal
Research centre Coimbra, 3508 Not yet recruiting
Coimbra, Portugal
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Research centre Evora, 3506 Not yet recruiting
Evora, Portugal
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Research centre Gaia, 3501 Not yet recruiting
Gaia, Portugal
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Research centre Lisbon, 3503 Not yet recruiting
Lisbon, Portugal
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Research centre Lisbon, 3504 Not yet recruiting
Lisbon, Portugal
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Research centre Lisbon, 3505 Not yet recruiting
Lisbon, Portugal
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Research centre Porto, 3507 Not yet recruiting
Porto, Portugal
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Romania
Research centre Bucuresti, 4002 Not yet recruiting
Bucuresti, Romania
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Research centre Bucuresti, 4005 Not yet recruiting
Bucuresti, Romania
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Research centre Cluj - Napoca, 4004 Not yet recruiting
Cluj - Napoca, Romania
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Research centre Cluy - Napoca, 4003 Not yet recruiting
Cluj-Napoca, Romania
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Singapore
Research centre Singapore, 6501 Recruiting
Singapore, Singapore
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Research centre Singapore, 6502 Recruiting
Singapore, Singapore
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Spain
Research centre Barcelona, 3401 Recruiting
Barcelona, Spain
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Research centre Barcelona, 3403 Recruiting
Barcelona, Spain
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Research centre Barcelona, 3405 Recruiting
Barcelona, Spain
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Research centre Huelva, 3408 Recruiting
Huelva, Spain
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Research centre Madrid, 3407 Recruiting
Madrid, Spain
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Research centre Madrid, 3402 Recruiting
Madrid, Spain
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Research centre Madrid, 3409 Recruiting
Madrid, Spain
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Research centre Madrid 3410 Recruiting
Madrid, Spain
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Research centre Vigo, 3404 Recruiting
Vigo, Spain
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Switzerland
Research centre Bern, 4106 Recruiting
Bern, Switzerland
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Research centre Bern, 4107 Not yet recruiting
Bern, Switzerland
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Research centre Geneva, 4101 Recruiting
Geneva, Switzerland
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Research centre Lausanne, 4104 Recruiting
Lausanne, Switzerland
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Research centre Liestal, 4108 Not yet recruiting
Liestal, Switzerland
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Research centre Lugano, 4105 Recruiting
Lugano, Switzerland
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United Kingdom
Research centre Belfast, 4420 Not yet recruiting
Belfast, United Kingdom
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Research centre Blackburn, 4404 Recruiting
Blackburn, United Kingdom
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Research centre Blackpool, 4408 Recruiting
Blackpool, United Kingdom
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Research centre Bournemouth, 4418 Not yet recruiting
Bournemouth, United Kingdom
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Research centre Brighton, 4405 Recruiting
Brighton, United Kingdom
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Research centre Cambridge, 4417 Recruiting
Cambridge, United Kingdom
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Research centre Cardiff, 4402 Recruiting
Cardiff, United Kingdom
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Research centre Glasgow, 4407 Recruiting
Glasgow, United Kingdom
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Research centre Leicester, 4421 Not yet recruiting
Leicester, United Kingdom
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Research centre Liverpool, 4001 Recruiting
Liverpool, United Kingdom
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Research centre Manchester, 4406 Recruiting
Manchester, United Kingdom
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Research centre Manchester, 4403 Recruiting
Manchester, United Kingdom
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Research centre Newcastle, 4413 Recruiting
Newcastle, United Kingdom
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Research centre Portsmouth, 4419 Not yet recruiting
Portsmouth, United Kingdom
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Research centre Rhyl, 4414 Not yet recruiting
Rhyl, United Kingdom
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Research centre Southampton, 4415 Recruiting
Southampton, United Kingdom
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Research centre Stevenage, 4412 Recruiting
Stevenage, United Kingdom
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Research centre Wolverhampton, 4422 Not yet recruiting
Wolverhampton, United Kingdom
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Sponsors and Collaborators
ECRI bv
Biosensors International
AstraZeneca
The Medicines Company
Investigators
Study Chair: Patrick Serruys, Prof. MD. Thoraxcenter, Erasmus, The Netherlands
Principal Investigator: Marco Valgimigli, MD Universitaria di Ferrara, Italy
Principal Investigator: Pascal Vranckx, MD UZ Virga Jesse Ziekenhuis, Belgium
Principal Investigator: Stephan Windecker, Prof. MD Inselspital, University Hospital Bern Switzerland
Principal Investigator: Christian Hamm, Prof. MD Kerckhoff Klinik GmbH, Germany
Principal Investigator: Peter Juni, Prof. MD Bern University Hospital, Switzerland
Principal Investigator: Gabriel Steg, Prof. MD. C.H.U. Bichat - Claude Bernard, France
Study Director: Gerrit-Anne van Es ECRI, the Netherlands
  More Information

No publications provided

Responsible Party: ECRI bv
ClinicalTrials.gov Identifier: NCT01813435     History of Changes
Other Study ID Numbers: ECRI-12-001, 02EU11
Study First Received: February 12, 2013
Last Updated: October 29, 2014
Health Authority: Australia: Human Research Ethics Committee
Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
Bulgaria: Ministry of Health
Canada: Health Canada
Denmark: Danish Health and Medicines Authority
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Italy: The Italian Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Singapore: Health Sciences Authority
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by ECRI bv:
CAD
ACS
All comers
DAPT
PCI

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Aspirin
Clopidogrel
Ticagrelor
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014