Atorvastatin Pre-Treatment Study In Asian Patients With Acute Coronary Syndrome

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NCT00728988

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Study Location
Pfizer Investigational Site
Guangzhou, Guangdong, 510100, China
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Contact
1-800-718-1021
[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acute Coronary Syndrome
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Non-ST elevated ACS; LDL-C > 80 mg/dl

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- ST elevated acute myocardial infarction; previously or currently treated with
atorvastatin or other statins

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  183. Chattanooga, Tennessee
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  568. Bangalore, Karnataka
  569. Mysore, Karnataka
  570. Shivamogga, Karnataka
  571. Indore, Madhya Pradesh
  572. Mumbai, Maharashtra
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  574. Nagpur, Maharashtra
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  576. Nagpur, Maharashtra
  577. Pune, Maharashtra
  578. Pune, Maharastra
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  584. Chennai, Tamilnadu
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  631. Nagoya, Aichi
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  660. Hachioji, Tokyo
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  678. Yangsan, Gyeongangnam-Do
  679. Anyang, Gyeonggi-Do
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  681. Jinju, Gyeongsangam-Do
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  785. Lublin,
  786. Lublin,
  787. Opole,
  788. Ostrowiec Swietokrzyski,
  789. Plock,
  790. Poznan,
  791. Radom,
  792. Rzeszow,
  793. Slupsk,
  794. Szczecin,
  795. Tarnow,
  796. Torun,
  797. Warsaw,
  798. Warszawa,
  799. Warszawa,
  800. Warszawa,
  801. Wloclawek,
  802. Zabrze,
  803. Zielona Gora,
  804. Cidra,
  805. San Juan,
  806. Arad,
  807. Baia Mare,
  808. Braila,
  809. Bucharest,
  810. Bucharest,
  811. Bucharest,
  812. Bucharest,
  813. Craiova,
  814. Oradea,
  815. Pitesti,
  816. Sibiu,
  817. Targu Mures,
  818. Timisoara,
  819. Barnaul,
  820. Chelyabinsk,
  821. Ekaterinburg,
  822. Ekaterinburg,
  823. Kaluga,
  824. Kazan,
  825. Kemerovo,
  826. Krasnoyarsk,
  827. Krasnoyarsk,
  828. Moscow Reg. Zhekeznodorozhniy,
  829. Moscow,
  830. Moscow,
  831. Moscow,
  832. Moscow,
  833. Moscow,
  834. Moscow,
  835. Moscow,
  836. Moscow,
  837. Moscow,
  838. Moscow,
  839. Moscow,
  840. Moscow,
  841. Moscow,
  842. Moscow,
  843. Moscow,
  844. Moscow,
  845. Moscow,
  846. Moscow,
  847. Moscow,
  848. Moscow,
  849. Moscow,
  850. Moscow,
  851. Moscow,
  852. Moscow,
  853. Nizhni Novgorod,
  854. Nizhny Novgorod,
  855. Nizhny Novgorod,
  856. Novosibirsk,
  857. Novosibirsk,
  858. Novosibirsk,
  859. Novosibirsk,
  860. Odintsovo,
  861. Penza,
  862. Perm,
  863. Rostov-On-Don,
  864. Ryazan,
  865. Saint Petersburg,
  866. Saint Petersburg,
  867. Saint Petersburg,
  868. Saint Petersburg,
  869. Saint Petersburg,
  870. Saint-Petersburg,
  871. Saint-Petersburg,
  872. Saint-Petersburg,
  873. Saint-Petersburg,
  874. Saint-Petersburg,
  875. Saratov,
  876. Saratov,
  877. St. Petersburg,
  878. St. Petersburg,
  879. St. Petersburg,
  880. Tomsk,
  881. Tver,
  882. Tyumen,
  883. Vasilievsky Island,
  884. Voronezh,
  885. Yaroslavl,
  886. Yaroslavl,
  887. Yaroslavl,
  888. Yaroslavl,
  889. Zhukovskiy,
  890. Singapore,
  891. Singapore,
  892. Banska Bystrica,
  893. Bratislava,
  894. Kosice,
  895. Kosice,
  896. Kosice,
  897. Kralovsky Chlmec,
  898. Liptovsky Hradok,
  899. Lucenec,
  900. Martin,
  901. Nitra,
  902. Port Elizabeth, Eastern Cape
  903. Port Elizabeth, Eastern Cape
  904. Bloemfontein, Free State
  905. Bloemfontein, Free State
  906. Centurion, Gauteng
  907. Wapadrand - Pretoria, Gauteng
  908. Durban, Kwa Zulu Natal
  909. Durban, Kwa Zulu Natal
  910. Durban, Kwa Zulu Natal
  911. Umhlanga, Kwa Zulu Natal
  912. Bellville, Western Cape
  913. Kuils River, Western Cape
  914. Pinelands, Western Cape
  915. Somerset West, Western Cape
  916. Worcester, Western Cape
  917. Johannesburg,
  918. Villajoyosa, Alicante
  919. Oviedo, Asturas
  920. Figueres, Gerona
  921. San Sebastian De Los Reyes, Madrid
  922. Almeria,
  923. Barcelona,
  924. Barcelona,
  925. Caceres,
  926. El Ejido,
  927. Granada,
  928. Lleida,
  929. Lugo,
  930. Madrid,
  931. Madrid,
  932. Madrid,
  933. Madrid,
  934. Madrid,
  935. Madrid,
  936. Malaga,
  937. Santiago De Compostela,
  938. Sevilla,
  939. Tarragona,
  940. Torrevieja,
  941. Valencia,
  942. Valladolid,
  943. Zaragoza,
  944. Eskilstuna,
  945. Halmstad,
  946. Helsingborg,
  947. Karlskoga,
  948. Karlstad,
  949. Koping,
  950. Lidkoping,
  951. Molndal,
  952. Skovde,
  953. Stockholm,
  954. Stockholm,
  955. Uppsala,
  956. Vaxjo,
  957. Lugano, Ticino
  958. Geneve,
  959. St Gallen,
  960. Zurich,
  961. Zurich,
  962. Besevler, Ankara
  963. Isanbul, Haseki
  964. Bornova, Izmir
  965. Ankara,
  966. Diyarbakir,
  967. Isparta,
  968. Kirikkale,
  969. Konya,
  970. Chernivtsy,
  971. Dnipropetrovsk,
  972. Dnipropetrovsk,
  973. Donetsk,
  974. Donetsk,
  975. Donetsk,
  976. Ivano-Frankivsk,
  977. Kharkiv,
  978. Kharkiv,
  979. Kharkiv,
  980. Kharkiv,
  981. Kharkiv,
  982. Kyiv,
  983. Kyiv,
  984. Kyiv,
  985. Kyiv,
  986. Lugansk,
  987. Lutsk,
  988. Lviv,
  989. Lviv,
  990. Mykolayiv,
  991. Odessa,
  992. Odessa,
  993. Simferopol,
  994. Vinnitsa,
  995. Zhaporizhzhya,
  996. Belfast, Antrim
  997. Belfast, Armagh
  998. Portadown, Armagh
  999. Ayr, Ayrshire
  1000. Kilmarnock, Ayrshire
  1001. Cambridge, Cambridgeshire
  1002. Chesterfield, Derbyshire
  1003. Dumfries, Dumfriesshire
  1004. Cottingham, East Yorkshire
  1005. Basildon, Essex
  1006. Chelmsford, Essex
  1007. Romford, Essex
  1008. Tunbridge Wells, Kent
  1009. Blackpool, Lancashire
  1010. Scunthorpe, Lincolnshire
  1011. Harrow, Middlesex
  1012. Worksop, Nottinghamshire
  1013. Doncaster, South Yorkshire
  1014. New Castle Upon Tyne, Tyne And Wear
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Acute Coronary SyndromeA Study to Evaluate the Safety of Apixaban in Acute Coronary Syndrome (ACS) Japanese Patients
NCT00852397
  1. Kasuga, Fukuoka
  2. Kitakyusyu, Fukuoka
  3. Kure, Hiroshima
  4. Sapporo, Hokkaido
  5. Uji, Kyoto
  6. Ikoma, Nara
  7. Hirakata, Osaka
  8. Kawachinagano, Osaka
  9. Matsubara, Osaka
  10. Yao, Osaka
  11. Wako, Saitama
  12. Sunto, Shizuoka
  13. Minato-Ku, Tokyo
  14. Shinagawa, Tokyo
  15. Gifu,
  16. Hiroshima,
  17. Kumamoto,
  18. Osaka,
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Acute Coronary SyndromeEffectiveness And Safety Of Dalteparin In Patients With Acute Coronary Syndromes Without ST Elevations In Clinical Practice
NCT00922766
  1. Ahmedabad, Gujarat
  2. Surat, Gujarat
  3. Hissar, Haryana
  4. Hissar, Haryana
  5. Bangalore, Karnataka
  6. Manglore, Karnataka
  7. Mysore, Karnataka
  8. Nagpur, Maharahtra
  9. Nashik, Maharahtra
  10. Ambernath (E), Maharashtra
  11. Nagpur, Maharashtra
  12. Nagpur, Maharashtra
  13. Nagpur, Maharashtra
  14. Nagpur, Maharashtra
  15. Nashik Road, Maharashtra
  16. Nashik Road, Maharashtra
  17. Nashik, Maharashtra
  18. Nashik, Maharashtra
  19. Thane, Maharashtra
  20. Bikaner, Rajasthan
  21. Jaipur, Rajasthan
  22. Jaipur, Rajasthan
  23. Chennai, Tamil Nadu
  24. Kolkata, West Bengal
ALL GENDERS
18 Years+
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MULTIPLE SITES
Acute Coronary SyndromeAtorvastatin Pre-Treatment Study In Asian Patients With Acute Coronary Syndrome
NCT00728988
  1. Guangzhou, Guangdong
  2. Changsha, Hunan
  3. Shen Yang, Liaoning
  4. Shenyang, Liaoning
  5. Qingdao, Shandong
  6. Hangzhou, Zhejiang
  7. Beijing,
  8. Beijing,
  9. Beijing,
  10. Shanghai,
  11. Shanghai,
  12. Shanghai,
  13. Seongnam-si, Gyeonggi-do, Korea
  14. Busan,
  15. Daegu,
  16. Daegu,
  17. Daegu,
  18. Daejeon,
  19. Gangneung-si, Gangwon-do,
  20. Gwang Ju,
  21. Jinju-si, Gyeongsangnam-do,
  22. Koyang-shi,
  23. Seoul,
  24. Seoul,
  25. Seoul,
  26. Ulsan,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Atorvastatin Pre-Treatment Study In Asian Patients With Acute Coronary Syndrome
Official Title  ICMJE A Prospective Randomized, Open-Label, Parallel-Group Comparative Study: Atorvastatin Pre-Treatment Versus Usual Care In Asian Patients With Acute Coronary Syndromes Undergoing Early Percutaneous Coronary Intervention
Brief Summary This present study is specifically designed to examine the efficacy and safety of a high pre-treatment dose of atorvastatin in Asian patients with NSTE-ACS in China and the Republic of Korea, by using a treatment paradigm similar to that employed in the ARMYDA-ACS study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Acute Coronary Syndrome
Intervention  ICMJE
  • Drug: Atorvastatin
    80mg 12 hours pre-Percutaneous Coronary Intervention (PCI), 40mg 2 hours pre-PCI and 40mg daily after PCI for 30 days.
  • Drug: Atorvastatin
    40mg daily after PCI for 30 days.
Study Arms  ICMJE
  • Experimental: Atorvastatin Group
    Intervention: Drug: Atorvastatin
  • Usual Care Group
    Intervention: Drug: Atorvastatin
Publications * Jang Y, Zhu J, Ge J, Kim YJ, Ji C, Lam W. Preloading with atorvastatin before percutaneous coronary intervention in statin-naïve Asian patients with non-ST elevation acute coronary syndromes: A randomized study. J Cardiol. 2014 May;63(5):335-43. doi: 10.1016/j.jjcc.2013.09.012. Epub 2013 Nov 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 14, 2010)		499
Original Estimated Enrollment  ICMJE
 (submitted: August 5, 2008)		350
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Non-ST elevated ACS; LDL-C > 80 mg/dl

Exclusion Criteria:

  • ST elevated acute myocardial infarction; previously or currently treated with atorvastatin or other statins
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China,   Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00728988
Other Study ID Numbers  ICMJE A2581161
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP