Effectiveness And Safety Of Dalteparin In Patients With Acute Coronary Syndromes Without ST Elevations In Clinical Practice

NCT00922766

Last updated date
Study Location
Pfizer Investigational Site
Ahmedabad, Gujarat, 380 051, India
Contact
1-800-718-1021

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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

- Male or female patients of 18 years or more presenting with chest pain will be potentially eligible for inclusion in the study if they satisfy the criteria for unstable coronary artery disease per the investigator's routine practice and have received at least one injection of Fragmin (dalteparin sodium) as part of routine clinical practice and is expected to be treated conservatively (without PCI or CABG within 48 hours) during the index hospitalization.

- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

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


- Patients who are contraindicated to receive this agent per the local approved
prescribing information.

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NCT00831441
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  778. Inowroclaw,
  779. Kielce,
  780. Koscierzyna,
  781. Krakow,
  782. Krakow,
  783. Lodz,
  784. Lodz,
  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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  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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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
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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,
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Advanced Information
Descriptive Information
Brief Title Effectiveness And Safety Of Dalteparin In Patients With Acute Coronary Syndromes Without ST Elevations In Clinical Practice
Official Title Effectiveness And Safety Of Dalteparin In Patients With Acute Coronary Syndromes Without ST Elevations In Clinical Practice
Brief Summary To collect data on safety and effectiveness of dalteparin in the management of non-ST segment elevated acute coronary syndromes in nursing home patients who will be treated conservatively (without percutaneous corornary intervention [PCI] or coronary artery bypass graft [CABG] within 48 hours).
Detailed Description t
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients management of non-ST segment elevated acute coronary syndromes in nursing home who will be treated conservatively (without percutaneous corornary intervention [PCI] or coronary artery bypass graft [CABG] within 48 hours).
Condition Acute Coronary Syndrome
Intervention Drug: Dalteparin
Patients prescribed dalteparin for non-ST segment elevated acute coronary syndromes in nursing home patients who will be treated conservatively (without corornary intervention [PCI] or coronary artery bypass graft [CABG] within 48 hours).
Study Groups/Cohorts 1.0
Intervention: Drug: Dalteparin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 7, 2011)
618
Original Estimated Enrollment
 (submitted: June 16, 2009)
1650
Actual Study Completion Date September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Male or female patients of 18 years or more presenting with chest pain will be potentially eligible for inclusion in the study if they satisfy the criteria for unstable coronary artery disease per the investigator's routine practice and have received at least one injection of Fragmin (dalteparin sodium) as part of routine clinical practice and is expected to be treated conservatively (without PCI or CABG within 48 hours) during the index hospitalization.
  • Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

  • Patients who are contraindicated to receive this agent per the local approved prescribing information.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries India
Removed Location Countries  
 
Administrative Information
NCT Number NCT00922766
Other Study ID Numbers A6301088
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2012